Trial Outcomes & Findings for Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age (NCT NCT02576639)
NCT ID: NCT02576639
Last Updated: 2017-08-11
Results Overview
Safety monitoring was conducted throughout the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
13 weeks
Results posted on
2017-08-11
Participant Flow
Participants were randomized in a 1:1:1:1:1 ratio to 5 treatment groups: placebo, CNP520 2 mg, CNP520 10 mg, CNP520 35 mg and CNP520 85 mg.
Participant milestones
| Measure |
Placebo
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
|
CNP520 2 mg
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
25
|
26
|
24
|
|
Overall Study
Pharmacodynamic Analysis Set
|
24
|
24
|
25
|
25
|
25
|
|
Overall Study
Pharmacokinetic Analysis Set
|
0
|
25
|
25
|
26
|
24
|
|
Overall Study
Safety Analysis Set
|
24
|
25
|
25
|
26
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
23
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
|
CNP520 2 mg
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
|
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.6 Years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
65.4 Years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
66.8 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
66.1 Years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
66.5 Years
STANDARD_DEVIATION 5.2 • n=21 Participants
|
66.3 Years
STANDARD_DEVIATION 4.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
63 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed.
Safety monitoring was conducted throughout the study.
Outcome measures
| Measure |
CNP520 2 mg
n=24 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=25 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=26 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Non-serious AEs
|
18 Participants
|
19 Participants
|
22 Participants
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 92Population: The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data.
CSF samples were collected by lumbar puncture for assessment.
Outcome measures
| Measure |
CNP520 2 mg
n=21 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=22 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=21 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=23 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=20 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Aβ 1-38
|
-2.34 Percentage change
Standard Deviation 6.969
|
-20.55 Percentage change
Standard Deviation 10.475
|
-62.48 Percentage change
Standard Deviation 6.202
|
-82.93 Percentage change
Standard Deviation 4.378
|
-89.5 Percentage change
Standard Deviation 1.676
|
|
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Aβ 1-40
|
-2.64 Percentage change
Standard Deviation 6.598
|
-22.64 Percentage change
Standard Deviation 9.937
|
-62.89 Percentage change
Standard Deviation 6.485
|
-83.16 Percentage change
Standard Deviation 4.227
|
-90.69 Percentage change
Standard Deviation 1.651
|
|
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Aβ 1-42
|
-2.58 Percentage change
Standard Deviation 5.189
|
-23.93 Percentage change
Standard Deviation 8.987
|
-64.28 Percentage change
Standard Deviation 6.086
|
-82.35 Percentage change
Standard Deviation 5.474
|
-89.68 Percentage change
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: Days 1, 91Population: The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.
Outcome measures
| Measure |
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: Cmax
Day 1 (n=25,25,26,24)
|
4.76 ng/mL
Standard Deviation 2.92
|
21.3 ng/mL
Standard Deviation 6.67
|
75.6 ng/mL
Standard Deviation 23.4
|
163 ng/mL
Standard Deviation 47.4
|
—
|
|
Summary of Plasma PK Parameter: Cmax
Day 91 (=23,22,24,20)
|
16.6 ng/mL
Standard Deviation 5.51
|
81 ng/mL
Standard Deviation 29.2
|
237 ng/mL
Standard Deviation 65.7
|
602 ng/mL
Standard Deviation 150
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 91Population: The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.
Outcome measures
| Measure |
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: AUCtau
Day 1 (n=25,25,26,24)
|
67.1 h*ng/mL
Standard Deviation 60.7
|
278 h*ng/mL
Standard Deviation 65.7
|
966 h*ng/mL
Standard Deviation 214
|
2300 h*ng/mL
Standard Deviation 479
|
—
|
|
Summary of Plasma PK Parameter: AUCtau
Day 91 (n=23,22,24,20)
|
313 h*ng/mL
Standard Deviation 117
|
1500 h*ng/mL
Standard Deviation 476
|
4450 h*ng/mL
Standard Deviation 1090
|
11200 h*ng/mL
Standard Deviation 3320
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 91Population: The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.
Outcome measures
| Measure |
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: Tmax
Day 1 (n=25,25,26,24)
|
2.5 hour
Interval 2.45 to 9.0
|
2.5 hour
Interval 2.5 to 6.02
|
2.5 hour
Interval 2.48 to 9.0
|
2.5 hour
Interval 2.42 to 12.0
|
—
|
|
Summary of Plasma PK Parameter: Tmax
Day 91 (n=23,22,24,20)
|
2.5 hour
Interval 0.0 to 12.1
|
2.5 hour
Interval 0.0 to 12.5
|
2.5 hour
Interval 0.0 to 12.0
|
2.5 hour
Interval 0.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 91Population: The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.
Outcome measures
| Measure |
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: Tlag
Day 1 (n=25,25,26,24)
|
0.5 hour
Interval 0.0 to 0.567
|
0.5 hour
Interval 0.0 to 2.5
|
0.5 hour
Interval 0.0 to 0.55
|
0 hour
Interval 0.0 to 2.5
|
—
|
|
Summary of Plasma PK Parameter: Tlag
Day 91 (n=23,22,24,20)
|
0 hour
Interval 0.0 to 0.0
|
0 hour
Interval 0.0 to 0.0
|
0 hour
Interval 0.0 to 0.0
|
0 hour
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.
Outcome measures
| Measure |
CNP520 2 mg
n=23 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=22 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=24 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=20 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: T1/2
|
150 hour
Standard Deviation 52.2
|
155 hour
Standard Deviation 40.9
|
155 hour
Standard Deviation 33.9
|
160 hour
Standard Deviation 22
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.
Outcome measures
| Measure |
CNP520 2 mg
n=23 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=22 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=24 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=20 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of PK Parameter: CLss/F
|
7620 mL/h
Standard Deviation 2620
|
7380 mL/h
Standard Deviation 2480
|
8460 mL/h
Standard Deviation 2790
|
8220 mL/h
Standard Deviation 2270
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.
Racc = the accumulation ratio . Blood samples were collected to assess Racc.
Outcome measures
| Measure |
CNP520 2 mg
n=23 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=22 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=24 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=20 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of Plasma PK Parameter: Racc
|
5.86 ratio
Standard Deviation 2.25
|
5.33 ratio
Standard Deviation 1.05
|
4.75 ratio
Standard Deviation 1.16
|
5.02 ratio
Standard Deviation 1.47
|
—
|
SECONDARY outcome
Timeframe: Days 1, 14, 28, 42, 56, 70 and 91Population: The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.
CSF samples were collected by lumbar puncture for assessment.
Outcome measures
| Measure |
CNP520 2 mg
n=25 Participants
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10 mg
n=25 Participants
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35 mg
n=26 Participants
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
n=24 Participants
CNP520 85 mg was taken qd orally for 13 weeks.
|
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Summary of CSF PK Concentrations
Day 1 (n=24,25,26,24)
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Summary of CSF PK Concentrations
Day 14 (n=3,4,4,4)
|
0.166 ng/mL
Standard Deviation 0.103
|
1.07 ng/mL
Standard Deviation 0.225
|
3.82 ng/mL
Standard Deviation 0.868
|
8.13 ng/mL
Standard Deviation 2.7
|
—
|
|
Summary of CSF PK Concentrations
Day 28 (n=5,2,7,5)
|
0.303 ng/mL
Standard Deviation 0.0731
|
1.48 ng/mL
Standard Deviation 0.106
|
4.48 ng/mL
Standard Deviation 1.02
|
12 ng/mL
Standard Deviation 4.12
|
—
|
|
Summary of CSF PK Concentrations
Day 42 (n=3,6,5,5)
|
0.314 ng/mL
Standard Deviation 0.0715
|
1.52 ng/mL
Standard Deviation 0.6
|
4 ng/mL
Standard Deviation 1.21
|
7.47 ng/mL
Standard Deviation 1.57
|
—
|
|
Summary of CSF PK Concentrations
Day 56 (n=5,5,2,4)
|
0.291 ng/mL
Standard Deviation 0.0605
|
1.28 ng/mL
Standard Deviation 0.177
|
5.03 ng/mL
Standard Deviation 2.69
|
8.04 ng/mL
Standard Deviation 5.69
|
—
|
|
Summary of CSF PK Concentrations
Day 70 (n=6,5,6,4)
|
0.231 ng/mL
Standard Deviation 0.149
|
1.04 ng/mL
Standard Deviation 0.212
|
4.62 ng/mL
Standard Deviation 0.753
|
8.71 ng/mL
Standard Deviation 0.71
|
—
|
|
Summary of CSF PK Concentrations
Day 91 (n=23,21,24,20)
|
0.305 ng/mL
Standard Deviation 0.099
|
1.44 ng/mL
Standard Deviation 0.431
|
4.52 ng/mL
Standard Deviation 0.946
|
10.4 ng/mL
Standard Deviation 3.26
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: This PK parameter was not analyzed because data was not collected.
CNP520 concentrations in plasma
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 91Population: This PK parameter was not analyzed because data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
CNP520 2mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
CNP520 10mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
CNP520 35mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
CNP520 85mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
|
CNP520 2mg
n=25 participants at risk
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10mg
n=25 participants at risk
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35mg
n=26 participants at risk
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85mg
n=24 participants at risk
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
|
CNP520 2mg
n=25 participants at risk
CNP520 2 mg was taken qd orally for 13 weeks.
|
CNP520 10mg
n=25 participants at risk
CNP520 10 mg was taken qd orally for 13 weeks.
|
CNP520 35mg
n=26 participants at risk
CNP520 35 mg was taken qd orally for 13 weeks.
|
CNP520 85mg
n=24 participants at risk
CNP520 85 mg was taken qd orally for 13 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Eye disorders
Asthenopia
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Eye disorders
Dry eye
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Eye disorders
Eye irritation
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Eye disorders
Eye pain
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Eye disorders
Eye pruritus
|
0.00%
0/24
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Eye disorders
Vision blurred
|
4.2%
1/24
|
4.0%
1/25
|
8.0%
2/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Eye disorders
Visual impairment
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
7.7%
2/26
|
4.2%
1/24
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
5/24
|
4.0%
1/25
|
12.0%
3/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24
|
4.0%
1/25
|
8.0%
2/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Faeces soft
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24
|
4.0%
1/25
|
12.0%
3/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Frequent bowel movements
|
4.2%
1/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24
|
8.0%
2/25
|
12.0%
3/25
|
7.7%
2/26
|
8.3%
2/24
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24
|
8.0%
2/25
|
0.00%
0/25
|
7.7%
2/26
|
0.00%
0/24
|
|
General disorders
Asthenia
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
General disorders
Fatigue
|
12.5%
3/24
|
0.00%
0/25
|
0.00%
0/25
|
7.7%
2/26
|
8.3%
2/24
|
|
General disorders
Feeling cold
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
General disorders
Influenza like illness
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
4.2%
1/24
|
|
General disorders
Injection site pain
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
8.3%
2/24
|
|
General disorders
Pain
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
General disorders
Puncture site pain
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
General disorders
Vessel puncture site haemorrhage
|
4.2%
1/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Infections and infestations
Abscess
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Infections and infestations
Hordeolum
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
4/24
|
8.0%
2/25
|
20.0%
5/25
|
15.4%
4/26
|
4.2%
1/24
|
|
Infections and infestations
Oral herpes
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Infections and infestations
Rhinitis
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Infections and infestations
Tinea pedis
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24
|
4.0%
1/25
|
8.0%
2/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Laceration
|
4.2%
1/24
|
0.00%
0/25
|
4.0%
1/25
|
7.7%
2/26
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
33.3%
8/24
|
8.0%
2/25
|
4.0%
1/25
|
11.5%
3/26
|
12.5%
3/24
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/24
|
0.00%
0/25
|
8.0%
2/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural complication
|
4.2%
1/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
8.3%
2/24
|
0.00%
0/25
|
12.0%
3/25
|
7.7%
2/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.2%
1/24
|
12.0%
3/25
|
16.0%
4/25
|
7.7%
2/26
|
12.5%
3/24
|
|
Injury, poisoning and procedural complications
Scratch
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Thermal burn
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Traumatic lumbar puncture
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Investigations
Amylase increased
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Investigations
Blood bilirubin increased
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Lipase increased
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Investigations
Weight decreased
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24
|
8.0%
2/25
|
12.0%
3/25
|
11.5%
3/26
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
6/24
|
8.0%
2/25
|
8.0%
2/25
|
11.5%
3/26
|
16.7%
4/24
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24
|
8.0%
2/25
|
4.0%
1/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
3/24
|
0.00%
0/25
|
0.00%
0/25
|
7.7%
2/26
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24
|
8.0%
2/25
|
0.00%
0/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24
|
8.0%
2/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Amnesia
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Nervous system disorders
Cognitive disorder
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness postural
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Dysarthria
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Head discomfort
|
4.2%
1/24
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
41.7%
10/24
|
44.0%
11/25
|
20.0%
5/25
|
19.2%
5/26
|
20.8%
5/24
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Sedation
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24
|
4.0%
1/25
|
0.00%
0/25
|
7.7%
2/26
|
4.2%
1/24
|
|
Nervous system disorders
Syncope
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Tension headache
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Psychiatric disorders
Irritability
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Psychiatric disorders
Libido decreased
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Psychiatric disorders
Obsessive thoughts
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
7.7%
2/26
|
4.2%
1/24
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24
|
8.0%
2/25
|
12.0%
3/25
|
11.5%
3/26
|
12.5%
3/24
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
2/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/24
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
2/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
4/24
|
8.0%
2/25
|
8.0%
2/25
|
7.7%
2/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.2%
1/24
|
4.0%
1/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
2/24
|
0.00%
0/25
|
8.0%
2/25
|
3.8%
1/26
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24
|
0.00%
0/25
|
0.00%
0/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24
|
0.00%
0/25
|
12.0%
3/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/24
|
4.0%
1/25
|
8.0%
2/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
3.8%
1/26
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/24
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Vascular disorders
Flushing
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
4.2%
1/24
|
|
Vascular disorders
Hot flush
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/26
|
0.00%
0/24
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER