Trial Outcomes & Findings for Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss (NCT NCT02132130)
NCT ID: NCT02132130
Last Updated: 2021-10-08
Results Overview
AE tables are below in the Adverse Events section of this report.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
week 52
Results posted on
2021-10-08
Participant Flow
A total of 22 subjects were enrolled in the study, of which 19 completed the study and 2 subjects discontinued due to lost to follow-up and 1 subject withdrew consent
Safety analysis set comprised all subjects who received study drug and with no protocol deviations having relevant impact on safety.
Participant milestones
| Measure |
CGF166 Dose 20 μL
single dose volume #1
|
CGF166 Dose 30 μL
single dose volume #2
|
CGF166 Dose 40 μL
single dose volume #3
|
CGF166 Dose 60 μL
single dose volume #4
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
10
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
CGF166 Dose 20 μL
single dose volume #1
|
CGF166 Dose 30 μL
single dose volume #2
|
CGF166 Dose 40 μL
single dose volume #3
|
CGF166 Dose 60 μL
single dose volume #4
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
Baseline characteristics by cohort
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μL
n=12 Participants
single dose volume #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 17.35 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 15.20 • n=7 Participants
|
52.8 Years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
51.3 Years
STANDARD_DEVIATION 19.30 • n=4 Participants
|
49.6 Years
STANDARD_DEVIATION 15.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: week 52Population: The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
AE tables are below in the Adverse Events section of this report.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: week 52Population: The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
AE tables are below in the Adverse Events section of this report.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Number of Adverse Events
|
9 Adverse events
|
16 Adverse events
|
13 Adverse events
|
8 Adverse events
|
46 Adverse events
|
PRIMARY outcome
Timeframe: Days 29, 57, 85, 113, 141, 169, 358, 537, 600Population: Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Summary of pure tone audiometry air conduction thresholds at frequency 0.125 KHz
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Baseline
|
63.3 DECIBELS
Standard Deviation 18.93
|
70.0 DECIBELS
Standard Deviation 14.62
|
70.0 DECIBELS
Standard Deviation 20.41
|
71.7 DECIBELS
Standard Deviation 16.07
|
69.3 DECIBELS
Standard Deviation 15.38
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 29
|
61.7 DECIBELS
Standard Deviation 20.82
|
70.4 DECIBELS
Standard Deviation 22.10
|
85.0 DECIBELS
Standard Deviation 10.80
|
75.0 DECIBELS
Standard Deviation 15.00
|
72.5 DECIBELS
Standard Deviation 19.62
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 57
|
61.7 DECIBELS
Standard Deviation 20.82
|
71.4 DECIBELS
Standard Deviation 15.34
|
86.3 DECIBELS
Standard Deviation 8.54
|
73.3 DECIBELS
Standard Deviation 15.28
|
73.1 DECIBELS
Standard Deviation 15.85
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 85
|
61.7 DECIBELS
Standard Deviation 25.66
|
66.3 DECIBELS
Standard Deviation 14.36
|
88.8 DECIBELS
Standard Deviation 24.96
|
75.0 DECIBELS
Standard Deviation 15.00
|
73.6 DECIBELS
Standard Deviation 21.16
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 113
|
60.0 DECIBELS
Standard Deviation 27.84
|
73.6 DECIBELS
Standard Deviation 14.33
|
92.5 DECIBELS
Standard Deviation 23.63
|
75.0 DECIBELS
Standard Deviation 15.00
|
75.5 DECIBELS
Standard Deviation 19.55
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 141
|
60.0 DECIBELS
Standard Deviation 27.84
|
68.8 DECIBELS
Standard Deviation 14.93
|
91.3 DECIBELS
Standard Deviation 22.87
|
73.3 DECIBELS
Standard Deviation 14.43
|
74.3 DECIBELS
Standard Deviation 21.65
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 169
|
—
|
72.1 DECIBELS
Standard Deviation 11.85
|
—
|
70.0 DECIBELS
Standard Deviation 7.07
|
71.7 DECIBELS
Standard Deviation 10.61
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 358
|
—
|
80.0 DECIBELS
Standard Deviation 14.14
|
—
|
72.5 DECIBELS
Standard Deviation 10.61
|
77.5 DECIBELS
Standard Deviation 12.55
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 537
|
—
|
82.5 DECIBELS
Standard Deviation 10.61
|
—
|
75.0 DECIBELS
|
80.0 DECIBELS
Standard Deviation 8.66
|
|
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Day 600
|
60.0 DECIBELS
Standard Deviation 27.84
|
77.5 DECIBELS
Standard Deviation 15.68
|
93.8 DECIBELS
Standard Deviation 9.46
|
82.5 DECIBELS
Standard Deviation 17.68
|
78.7 DECIBELS
Standard Deviation 18.77
|
PRIMARY outcome
Timeframe: Days 29, 57, 85, 113, 141, 169, 358,537, EoSPopulation: Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Summary of pure tone audiometry bone conduction thresholds by time and frequency 0.250 KHz
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Baseline
|
55.0 decibels
Standard Deviation 0.00
|
64.2 decibels
Standard Deviation 28.83
|
87.5 decibels
Standard Deviation 43.5
|
55.0 decibels
Standard Deviation 0.00
|
65.9 decibels
Standard Deviation 28.81
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 29
|
55.0 decibels
Standard Deviation 0.00
|
73.8 decibels
Standard Deviation 31.49
|
63.8 decibels
Standard Deviation 42.11
|
55.0 decibels
Standard Deviation 0.00
|
66.8 decibels
Standard Deviation 29.01
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 57
|
50.0 decibels
Standard Deviation 8.66
|
56.8 decibels
Standard Deviation 7.83
|
90.0 decibels
Standard Deviation 40.41
|
55.0 decibels
Standard Deviation 0.00
|
61.9 decibels
Standard Deviation 21.99
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 85
|
48.3 decibels
Standard Deviation 11.55
|
90.0 decibels
Standard Deviation 40.41
|
90.0 decibels
Standard Deviation 40.41
|
51.7 decibels
Standard Deviation 5.77
|
72.9 decibels
Standard Deviation 34.68
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 169
|
0 decibels
Standard Deviation 0
|
48.6 decibels
Standard Deviation 8.52
|
—
|
50.0 decibels
Standard Deviation 7.07
|
48.9 decibels
Standard Deviation 7.82
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 358
|
—
|
45.0 decibels
Standard Deviation 8.16
|
—
|
55.00 decibels
Standard Deviation 0.00
|
48.3 decibels
Standard Deviation 8.16
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 537
|
—
|
50 decibels
Standard Deviation 7.07
|
—
|
40 decibels
|
46.7 decibels
Standard Deviation 7.64
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
End of Study
|
48.3 decibels
Standard Deviation 11.55
|
61.5 decibels
Standard Deviation 22.37
|
90.0 decibels
Standard Deviation 40.41
|
50.0 decibels
Standard Deviation 7.07
|
64.2 decibels
Standard Deviation 27.50
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 113
|
50.0 decibels
Standard Deviation 8.66
|
57.7 decibels
Standard Deviation 23.17
|
86.3 decibels
Standard Deviation 45.16
|
53.3 decibels
Standard Deviation 2.89
|
61.4 decibels
Standard Deviation 27.26
|
|
Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Day 141
|
46.7 decibels
Standard Deviation 14.43
|
51.3 decibels
Standard Deviation 7.50
|
90.0 decibels
Standard Deviation 40.41
|
51.7 decibels
Standard Deviation 5.77
|
61.4 decibels
Standard Deviation 27.97
|
PRIMARY outcome
Timeframe: Week 52Population: Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Summary of change from baseline in pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
125 hz
|
-4.2 decibels
Standard Deviation 9.46
|
6.7 decibels
Standard Deviation 10.19
|
26.3 decibels
Standard Deviation 17.02
|
5.0 decibels
Standard Deviation 4.33
|
8.5 decibels
Standard Deviation 13.88
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
250 Hz
|
-3.3 decibels
Standard Deviation 6.29
|
6.0 decibels
Standard Deviation 9.20
|
26.3 decibels
Standard Deviation 26.65
|
0.8 decibels
Standard Deviation 1.44
|
7.7 decibels
Standard Deviation 15.52
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
500 Hz
|
0 decibels
Standard Deviation 5.00
|
7.7 decibels
Standard Deviation 11.00
|
26.3 decibels
Standard Deviation 23.32
|
0.8 decibels
Standard Deviation 1.44
|
9.1 decibels
Standard Deviation 14.91
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
3,000 Hz
|
2.5 decibels
Standard Deviation 2.50
|
5.8 decibels
Standard Deviation 11.60
|
11.9 decibels
Standard Deviation 11.06
|
-4.2 decibels
Standard Deviation 3.82
|
5.1 decibels
Standard Deviation 10.59
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
4,000 Hz
|
0.8 decibels
Standard Deviation 1.44
|
4.4 decibels
Standard Deviation 12.97
|
5.0 decibels
Standard Deviation 4.08
|
-0.8 decibels
Standard Deviation 3.82
|
3.3 decibels
Standard Deviation 9.83
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
6,000 Hz
|
1.7 decibels
Standard Deviation 2.89
|
3.3 decibels
Standard Deviation 13.16
|
7.5 decibels
Standard Deviation 15.00
|
1.7 decibels
Standard Deviation 6.29
|
3.2 decibels
Standard Deviation 11.60
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
8,000 Hz
|
1.7 decibels
Standard Deviation 2.89
|
2.9 decibels
Standard Deviation 15.33
|
-8.8 decibels
Standard Deviation 17.50
|
4.2 decibels
Standard Deviation 7.22
|
0.8 decibels
Standard Deviation 13.94
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
1,000 Hz
|
-0.8 decibels
Standard Deviation 3.82
|
8.1 decibels
Standard Deviation 10.51
|
16.9 decibels
Standard Deviation 8.98
|
5.8 decibels
Standard Deviation 1.44
|
8.2 decibels
Standard Deviation 9.89
|
|
Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
2,000 Hz
|
0.8 decibels
Standard Deviation 6.29
|
6.0 decibels
Standard Deviation 11.40
|
6.9 decibels
Standard Deviation 8.51
|
0.8 decibels
Standard Deviation 3.82
|
4.8 decibels
Standard Deviation 9.48
|
PRIMARY outcome
Timeframe: Week 52Population: Pharmacodynamics (PD) analysis set was comprised of all subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.
Summary of change from baseline in Non-treated ear's pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
3,000 Hz
|
0 decibels
Standard Deviation 5.00
|
0.2 decibels
Standard Deviation 4.94
|
0.6 decibels
Standard Deviation 1.25
|
-7.5 decibels
Standard Deviation 2.50
|
5.1 decibels
Standard Deviation 4.84
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
4,000 Hz
|
-2.5 decibels
Standard Deviation 6.61
|
1.0 decibels
Standard Deviation 3.76
|
1.3 decibels
Standard Deviation 2.50
|
-0.8 decibels
Standard Deviation 6.29
|
3.3 decibels
Standard Deviation 4.25
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
6,000 Hz
|
-0.8 decibels
Standard Deviation 1.44
|
-0.6 decibels
Standard Deviation 3.56
|
-8.1 decibels
Standard Deviation 11.79
|
-1.7 decibels
Standard Deviation 5.77
|
3.2 decibels
Standard Deviation 6.19
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
8,000 Hz
|
-3.3 decibels
Standard Deviation 5.77
|
-4.2 decibels
Standard Deviation 10.78
|
-8.8 decibels
Standard Deviation 17.50
|
-0.8 decibels
Standard Deviation 6.29
|
0.8 decibels
Standard Deviation 10.83
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
500 Hz
|
0.8 decibels
Standard Deviation 1.44
|
6.0 decibels
Standard Deviation 18.87
|
-2.5 decibels
Standard Deviation 3.54
|
-1.7 decibels
Standard Deviation 2.50
|
9.1 decibels
Standard Deviation 14.32
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
1,000 Hz
|
1.7 decibels
Standard Deviation 2.89
|
1.7 decibels
Standard Deviation 4.81
|
0 decibels
Standard Deviation 2.04
|
-1.7 decibels
Standard Deviation 1.44
|
8.2 decibels
Standard Deviation 3.83
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
2,000 Hz
|
0.8 decibels
Standard Deviation 2.89
|
0.2 decibels
Standard Deviation 7.27
|
-0.6 decibels
Standard Deviation 2.39
|
-2.5 decibels
Standard Deviation 4.33
|
4.8 decibels
Standard Deviation 5.66
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
125 hz
|
-2.5 decibels
Standard Deviation 6.61
|
1.7 decibels
Standard Deviation 4.92
|
-3.1 decibels
Standard Deviation 2.39
|
-1.7 decibels
Standard Deviation 3.82
|
8.5 decibels
Standard Deviation 4.87
|
|
Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
250 Hz
|
0 decibels
Standard Deviation 8.66
|
2.3 decibels
Standard Deviation 5.48
|
-2.5 decibels
Standard Deviation 3.54
|
0.8 decibels
Standard Deviation 2.89
|
7.7 decibels
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: PD analysis set
BAERs was assessed with standard techniques for clinically significant threshold improvements compared to baseline levels.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Number of Participants With Change in Brainstem Auditory Evoked Responses (BAER) Compared to Pretreatment Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: PD Analysis Set
Response in vestibular assessments (Head impulse test (HIT), Vestibular evoked myogenic potential (VEMP), Subjective visual vertical (SVV)) to CGF166.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Number of Participants With Response in Vestibular Function in Treated Ear Compared to Pretreatment Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: PD analysis set
Clinically signficant speech recognition improvement (word and/or sentence) following treatment. The individual auditory assessments were speech audiometry, AzBio sentence test, consonant nucleus consonant test, word recognition, Hearing-in-Noise Test (HINT), Brainstem auditory evoked response evaluations (BAER), Distortion product otoacoustic emission testing (DPOE) and shoebox audiometry.
Outcome measures
| Measure |
CGF166 Dose 20 μL
n=3 Participants
single dose volume #1
|
CGF166 Dose 30 μLEdit Single Dose Volume #2
n=12 Participants
single dose #2
|
CGF166 Dose 40 μL
n=4 Participants
single dose volume #3
|
CGF166 Dose 60 μL
n=3 Participants
single dose volume #4
|
Total
n=22 Participants
Number of participants
|
|---|---|---|---|---|---|
|
Number of Participants With Changes in Auditory Functions (Speech Recognition) and Vestibular Functions Before and After IL Infusion of CGF166 Between the Study Ear and the Contralateral Ear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
CGF166 20 μL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CGF166 30 μL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CGF166 40 μL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CGF166 60 μL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CGF166 20 μL
n=3 participants at risk
CCGF166X2201 20 μL
|
CGF166 30 μL
n=12 participants at risk
CCGF166X2201 30 μL
|
CGF166 40 μL
n=4 participants at risk
CCGF166X2201 40 μL
|
CGF166 60 μL
n=3 participants at risk
CCGF166X2201 60 μL
|
|---|---|---|---|---|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Ear pain
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
100.0%
4/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Immune system disorders
Food allergy
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Immune system disorders
Seasonal allergy
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
66.7%
2/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Nervous system disorders
Vestibular migraine
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
33.3%
1/3 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
AEs are any untoward sign or symptom that occurs during the study treatment
|
Additional Information
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER