Trial Outcomes & Findings for Reduction in Pain Intensity Following IV or Oral Pain-relieving Products (NCT NCT02678416)
NCT ID: NCT02678416
Last Updated: 2020-02-05
Results Overview
The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
79 participants
Primary outcome timeframe
within 6 hours
Results posted on
2020-02-05
Participant Flow
A total of 79 participants were enrolled in the study. 12 participants in Part 1 and 66 participants in Part 2 were randomized to sequence, and received at least one dose of the study treatment.
One participant in Part 2 was randomized but discontinued without receiving treatment due to an adverse event.
Participant milestones
| Measure |
Part 1
All participants receive all products in random sequence
|
|---|---|
|
Part 1
STARTED
|
12
|
|
Part 1
Safety Population
|
12
|
|
Part 1
Modified Intent to Treat (mITT)
|
12
|
|
Part 1
Per Protocol Population
|
8
|
|
Part 1
COMPLETED
|
11
|
|
Part 1
NOT COMPLETED
|
1
|
|
Part 2
STARTED
|
67
|
|
Part 2
Treated (Safety Population)
|
66
|
|
Part 2
Modified Intent to Treat Population
|
66
|
|
Part 2
Pharmacokinetic Population
|
65
|
|
Part 2
Per Protocol Population
|
64
|
|
Part 2
COMPLETED
|
64
|
|
Part 2
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Part 1
All participants receive all products in random sequence
|
|---|---|
|
Part 1
Withdrawal by Subject
|
1
|
|
Part 2
Adverse Event
|
2
|
|
Part 2
Withdrawal by Subject
|
1
|
Baseline Characteristics
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
Baseline characteristics by cohort
| Measure |
Part 1
n=12 Participants
All participants who received a drug product in Part 1
|
Part 2
n=66 Participants
All participants who received a drug product in Part 2
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
n=93 Participants
|
26.5 years
n=4 Participants
|
26.9 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race, White · Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race, White · Hispanic or Latino
|
0 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: within 6 hoursPopulation: Completers, defined as participants who were enrolled in the study, took the entire dose of all study drugs, and provided all pain intensity assessments.
The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).
Outcome measures
| Measure |
IV Acetaminophen
n=11 Participants
All participants received IV acetaminophen
|
Oral Acetaminophen
n=11 Participants
All participants received oral acetaminophen
|
Placebo
n=11 Participants
All participants received placebo
|
Morphine
n=11 Participants
All participants received morphine
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
|
0.73 score on a scale
Standard Deviation 1.104
|
-0.64 score on a scale
Standard Deviation 1.804
|
-0.36 score on a scale
Standard Deviation 1.567
|
0.36 score on a scale
Standard Deviation 1.206
|
SECONDARY outcome
Timeframe: within 6 hoursPopulation: Per-Protocol Population, defined as participants who were enrolled in the study, have taken the entire dose of all study drugs, and provided all pain intensity assessments designed for the UVB Burn Pain Model without a major protocol deviation.
Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6
Outcome measures
| Measure |
IV Acetaminophen
n=64 Participants
All participants received IV acetaminophen
|
Oral Acetaminophen
n=64 Participants
All participants received oral acetaminophen
|
Placebo
n=64 Participants
All participants received placebo
|
Morphine
n=64 Participants
All participants received morphine
|
|---|---|---|---|---|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
Baseline
|
5.4 scores on a scale
Standard Deviation 1.30
|
5.5 scores on a scale
Standard Deviation 1.40
|
5.5 scores on a scale
Standard Deviation 1.32
|
5.6 scores on a scale
Standard Deviation 1.40
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
0.25 Hours
|
5.2 scores on a scale
Standard Deviation 1.39
|
5.3 scores on a scale
Standard Deviation 1.48
|
5.5 scores on a scale
Standard Deviation 1.28
|
4.9 scores on a scale
Standard Deviation 1.56
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
0.5 Hours
|
5.0 scores on a scale
Standard Deviation 1.34
|
5.1 scores on a scale
Standard Deviation 1.36
|
5.3 scores on a scale
Standard Deviation 1.28
|
4.7 scores on a scale
Standard Deviation 1.50
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
0.75 Hours
|
5.0 scores on a scale
Standard Deviation 1.37
|
5.1 scores on a scale
Standard Deviation 1.30
|
5.4 scores on a scale
Standard Deviation 1.26
|
4.7 scores on a scale
Standard Deviation 1.62
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
1 Hour
|
5.0 scores on a scale
Standard Deviation 1.44
|
4.9 scores on a scale
Standard Deviation 1.23
|
5.2 scores on a scale
Standard Deviation 1.34
|
4.6 scores on a scale
Standard Deviation 1.55
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
2 Hours
|
5.3 scores on a scale
Standard Deviation 1.13
|
5.1 scores on a scale
Standard Deviation 1.26
|
5.6 scores on a scale
Standard Deviation 1.28
|
5.1 scores on a scale
Standard Deviation 1.50
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
3 Hours
|
5.4 scores on a scale
Standard Deviation 1.30
|
5.2 scores on a scale
Standard Deviation 1.44
|
5.5 scores on a scale
Standard Deviation 1.23
|
5.0 scores on a scale
Standard Deviation 1.67
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
4 Hours
|
5.5 scores on a scale
Standard Deviation 1.17
|
5.4 scores on a scale
Standard Deviation 1.40
|
5.5 scores on a scale
Standard Deviation 1.30
|
5.2 scores on a scale
Standard Deviation 1.42
|
|
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
6 Hours
|
5.6 scores on a scale
Standard Deviation 1.32
|
5.5 scores on a scale
Standard Deviation 1.30
|
5.5 scores on a scale
Standard Deviation 1.34
|
5.4 scores on a scale
Standard Deviation 1.45
|
Adverse Events
Part 1: IV Acetaminophen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Oral Acetaminophen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Morphine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2: IV Acetaminophen
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2: Oral Acetaminophen
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: Morphine
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: IV Acetaminophen
n=12 participants at risk
All participants received IV acetaminophen
|
Part 1: Oral Acetaminophen
n=12 participants at risk
All participants received oral acetaminophen
|
Part 1: Placebo
n=12 participants at risk
All participants received placebo
|
Part 1: Morphine
n=12 participants at risk
All participants received morphine
|
Part 2: IV Acetaminophen
n=64 participants at risk
All participants received IV acetaminophen
|
Part 2: Oral Acetaminophen
n=65 participants at risk
All participants received oral acetaminophen
|
Part 2: Placebo
n=65 participants at risk
All participants received placebo
|
Part 2: Morphine
n=66 participants at risk；n=64 participants at risk
All participants received morphine
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
4.5%
3/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
13.6%
9/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
7.6%
5/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
33.3%
4/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.1%
2/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
30.3%
20/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
6.2%
4/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
4.6%
3/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
6.1%
4/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.1%
2/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
7.6%
5/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
33.3%
4/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
15.2%
10/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
7.6%
5/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
4.5%
3/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Axillary Pain
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
25.0%
3/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Chills
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Feeling Of Relaxations
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Eye disorders
Asthenopia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Eye Movement Disorder
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
8.3%
1/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Eye disorders
Visual impairment
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.1%
2/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Feeling abnormal
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Feeling hot
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Injection site rash
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
General disorders
Thirst
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/12 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.6%
1/64 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
0.00%
0/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
1.5%
1/65 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
3.0%
2/66 • From first dose up to Day 46
Safety population included participants enrolled in the study that received any quantity of study medications.
|
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Phone: 800-556-3314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators will be part of the primary publication. Each investigator may publish on the data from subjects enrolled at their site after the initial publication has been submitted.
- Publication restrictions are in place
Restriction type: OTHER