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Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02132130
Collaborator
(none)
22
Enrollment
4
Locations
5
Arms
65.5
Actual Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This study evaluated the safety, tolerability, and potential efficacy of CGF166 and the associated delivery procedures in patients with severe-to-profound unilateral or bilateral hearing loss. Eligible patients were required to have documented, non-fluctuating hearing loss.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Three-part, Multicenter, Open Label, Single Dose Study to Assess the Safety, Tolerability, and Efficacy of Intra Labyrinthine (IL) CGF166 in Patients With Severe-to-profound Hearing Loss
Actual Study Start Date :
Jun 23, 2014
Actual Primary Completion Date :
Dec 9, 2019
Actual Study Completion Date :
Dec 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: CGF166 dose 20 uL

single dose volume #1

Drug: CGF166
CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
Experimental: CGF166 dose 30 and 40 uL

single dose volume #2

Drug: CGF166
CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
Experimental: CGF166 dose 40 uL

single dose volume #3

Drug: CGF166
CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
Experimental: CGF166 dose 60 uL

single dose volume #4

Drug: CGF166
CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
Experimental: CFG166 dose 30 uL

Single dose volume #5

Drug: CGF166
CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Events [week 52]

    AE tables are below in the Adverse Events section of this report.

  2. Number of Adverse Events [week 52]

    AE tables are below in the Adverse Events section of this report.

  3. Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values [Days 29, 57, 85, 113, 141, 169, 358, 537, 600]

    Summary of pure tone audiometry air conduction thresholds at frequency 0.125 KHz

  4. Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency [Days 29, 57, 85, 113, 141, 169, 358,537, EoS]

    Summary of pure tone audiometry bone conduction thresholds by time and frequency 0.250 KHz

  5. Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit [Week 52]

    Summary of change from baseline in pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.

  6. Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit [Week 52]

    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.

Secondary Outcome Measures

  1. Number of Participants With Change in Brainstem Auditory Evoked Responses (BAER) Compared to Pretreatment Values [24 months]

    BAERs was assessed with standard techniques for clinically significant threshold improvements compared to baseline levels.

  2. Number of Participants With Response in Vestibular Function in Treated Ear Compared to Pretreatment Values [24 months]

    Response in vestibular assessments (Head impulse test (HIT), Vestibular evoked myogenic potential (VEMP), Subjective visual vertical (SVV)) to CGF166.

  3. 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 [24 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

For all Parts A, B and C of the study,

Inclusion criteria:

  1. Written informed consent must be obtained before any assessment is performed.

  2. For all Parts A, B and C of the study, male or female patients, 18 to 75 years old, inclusive, with severe-to-profound bilateral hearing loss or unilateral hearing loss with intact vestibular function in the nonoperative ear. Non-fluctuating severe-to-profound hearing loss is required for the study ear and is defined as:

  • PTA within 10 dB of the PTA obtained at least 11 months previously.

  • Word recognition within 20% of previous test at least 11 months previously

  1. Candidate ear ("study ear"): Minimal residual hearing based on the pure tone average of 0.5, 1, 2, and 4 kHz thresholds of ≤110 dB HL

  2. Candidate ear ("study ear"): Pure tone audiometric thresholds of ≥50 dB HL for each testable octave frequency of 0.125 and 0.250 kHz, ≥70 dB HL for each testable octave frequency from 0.5 through 8 kHz and sentence recognition scores ≤50% at screening.

  3. Patients with intact vestibular function in at least one ear (non-study ear) as measured by vestibular evoked myogenic potential (VEMP) 7. Able to communicate well with the investigator, to understand and comply with the requirements of the study 8. MRI scan within 6 months or at screening to confirm suitability for inner ear surgery 9. Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) <45 kg/m2. BMI = Body weight (kg) / [Height (m)]2

Exclusion Criteria:

  1. Patients with hearing loss caused by genetic/developmental disorders, e.g., cochlea aplasia

  2. Patients with existing conductive hearing loss or mixed hearing loss as judged by the Principal Investigator following a thorough review of all of the trial hearing assessments;

  3. Patients with a history of cochlear implant in the study ear

  4. Hearing loss due to any other cause that would not be expected to respond to hair cell regeneration, for example mechanical trauma or central auditory lesions or lack of an auditory nerve

  5. Patients who will require ototoxic drugs as routine therapy over the course of the study, for example cystic fibrosis patients

  6. Any contraindication to the planned surgery or anesthesia as determined by the surgeon or anesthesiologist

  7. Previous surgery in the study ear

  8. Any otological history, such as chronic otitis, cholesteatoma, tympanic membrane perforation, that suggests poor candidacy for cochlear implant or inner ear surgery or suggests potential interference with study auditory or vestibular function tests

  9. Pregnant women

  10. Abnormal vital signs and/or ECG that suggest potential contraindication for planned study anesthesia

  11. Past serious adverse reaction to anesthesia

  12. Meniere's Disease

  13. History of radiation therapy to the head and neck

  14. Participation in a clinical trial within the last 30 days

  15. Immunocompromised patients, as judged by the investigators based on patient history, physical exam and CBC

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Kansas City Kansas United States 66160
2 Novartis Investigative Site Baltimore Maryland United States 21287
3 Novartis Investigative Site New York New York United States 10032
4 Novartis Investigative Site Portland Oregon United States 97239

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02132130
Other Study ID Numbers:
  • CCGF166X2201
First Posted:
May 7, 2014
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
gene therapy
unilateral hearing loss
bilateral hearing loss
balance
vestibular
cochlear implant
hearing restoration
Additional relevant MeSH terms:
Hearing Loss
Deafness

Study Results

Participant Flow

Recruitment Details 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
Pre-assignment Detail Safety analysis set comprised all subjects who received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4
Period Title: Overall Study
STARTED 3 12 4 3
COMPLETED 3 10 4 2
NOT COMPLETED 0 2 0 1

Baseline Characteristics

Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Total of all reporting groups
Overall Participants 3 12 4 3 22
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
3
100%
9
75%
3
75%
2
66.7%
17
77.3%
>=65 years
0
0%
3
25%
1
25%
1
33.3%
5
22.7%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
39.0
(17.35)
50.8
(15.20)
52.8
(13.40)
51.3
(19.30)
49.6
(15.16)
Sex: Female, Male (Count of Participants)
Female
2
66.7%
3
25%
1
25%
1
33.3%
7
31.8%
Male
1
33.3%
9
75%
3
75%
2
66.7%
15
68.2%
Race/Ethnicity, Customized (Count of Participants)
Caucasian
3
100%
10
83.3%
4
100%
3
100%
20
90.9%
Asian
0
0%
1
8.3%
0
0%
0
0%
1
4.5%
Other
0
0%
1
8.3%
0
0%
0
0%
1
4.5%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Adverse Events
Description AE tables are below in the Adverse Events section of this report.
Time Frame week 52

Outcome Measure Data

Analysis Population Description
The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μLEdit Single Dose Volume #2 CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
Count of Participants [Participants]
3
100%
6
50%
4
100%
3
100%
16
72.7%
2. Primary Outcome
Title Number of Adverse Events
Description AE tables are below in the Adverse Events section of this report.
Time Frame week 52

Outcome Measure Data

Analysis Population Description
The Safety Analysis Set was comprised of all subjects that received study drug and with no protocol deviations having relevant impact on safety.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of AEs
Measure Participants 3 12 4 3 22
Number [Adverse events]
9
16
13
8
46
3. Primary Outcome
Title Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
Description Summary of pure tone audiometry air conduction thresholds at frequency 0.125 KHz
Time Frame Days 29, 57, 85, 113, 141, 169, 358, 537, 600

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
Baseline
63.3
(18.93)
70.0
(14.62)
70.0
(20.41)
71.7
(16.07)
69.3
(15.38)
Day 29
61.7
(20.82)
70.4
(22.10)
85.0
(10.80)
75.0
(15.00)
72.5
(19.62)
Day 57
61.7
(20.82)
71.4
(15.34)
86.3
(8.54)
73.3
(15.28)
73.1
(15.85)
Day 85
61.7
(25.66)
66.3
(14.36)
88.8
(24.96)
75.0
(15.00)
73.6
(21.16)
Day 113
60.0
(27.84)
73.6
(14.33)
92.5
(23.63)
75.0
(15.00)
75.5
(19.55)
Day 141
60.0
(27.84)
68.8
(14.93)
91.3
(22.87)
73.3
(14.43)
74.3
(21.65)
Day 169
72.1
(11.85)
70.0
(7.07)
71.7
(10.61)
Day 358
80.0
(14.14)
72.5
(10.61)
77.5
(12.55)
Day 537
82.5
(10.61)
75.0
80.0
(8.66)
Day 600
60.0
(27.84)
77.5
(15.68)
93.8
(9.46)
82.5
(17.68)
78.7
(18.77)
4. Primary Outcome
Title Summary Pure Tone Audiometry Bone Conduction Thresholds in Treated Ear by Time and Frequency
Description Summary of pure tone audiometry bone conduction thresholds by time and frequency 0.250 KHz
Time Frame Days 29, 57, 85, 113, 141, 169, 358,537, EoS

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
Baseline
55.0
(0.00)
64.2
(28.83)
87.5
(43.5)
55.0
(0.00)
65.9
(28.81)
Day 29
55.0
(0.00)
73.8
(31.49)
63.8
(42.11)
55.0
(0.00)
66.8
(29.01)
Day 57
50.0
(8.66)
56.8
(7.83)
90.0
(40.41)
55.0
(0.00)
61.9
(21.99)
Day 85
48.3
(11.55)
90.0
(40.41)
90.0
(40.41)
51.7
(5.77)
72.9
(34.68)
Day 113
50.0
(8.66)
57.7
(23.17)
86.3
(45.16)
53.3
(2.89)
61.4
(27.26)
Day 141
46.7
(14.43)
51.3
(7.50)
90.0
(40.41)
51.7
(5.77)
61.4
(27.97)
Day 169
0
(0)
48.6
(8.52)
50.0
(7.07)
48.9
(7.82)
Day 358
45.0
(8.16)
55.00
(0.00)
48.3
(8.16)
Day 537
50
(7.07)
40
46.7
(7.64)
End of Study
48.3
(11.55)
61.5
(22.37)
90.0
(40.41)
50.0
(7.07)
64.2
(27.50)
5. Primary Outcome
Title Summary of Change From Baseline in Treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
Description Summary of change from baseline in pure tone audiometry air conduction threshold by frequency for last study visit is presented in table below.
Time Frame Week 52

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
125 hz
-4.2
(9.46)
6.7
(10.19)
26.3
(17.02)
5.0
(4.33)
8.5
(13.88)
250 Hz
-3.3
(6.29)
6.0
(9.20)
26.3
(26.65)
0.8
(1.44)
7.7
(15.52)
500 Hz
0
(5.00)
7.7
(11.00)
26.3
(23.32)
0.8
(1.44)
9.1
(14.91)
1,000 Hz
-0.8
(3.82)
8.1
(10.51)
16.9
(8.98)
5.8
(1.44)
8.2
(9.89)
2,000 Hz
0.8
(6.29)
6.0
(11.40)
6.9
(8.51)
0.8
(3.82)
4.8
(9.48)
3,000 Hz
2.5
(2.50)
5.8
(11.60)
11.9
(11.06)
-4.2
(3.82)
5.1
(10.59)
4,000 Hz
0.8
(1.44)
4.4
(12.97)
5.0
(4.08)
-0.8
(3.82)
3.3
(9.83)
6,000 Hz
1.7
(2.89)
3.3
(13.16)
7.5
(15.00)
1.7
(6.29)
3.2
(11.60)
8,000 Hz
1.7
(2.89)
2.9
(15.33)
-8.8
(17.50)
4.2
(7.22)
0.8
(13.94)
6. Primary Outcome
Title Summary of Change From Baseline in Non-treated Ear's Pure Tone Audiometry Air Conduction Threshold by Frequency for Last Study Visit
Description 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.
Time Frame Week 52

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
125 hz
-2.5
(6.61)
1.7
(4.92)
-3.1
(2.39)
-1.7
(3.82)
8.5
(4.87)
250 Hz
0
(8.66)
2.3
(5.48)
-2.5
(3.54)
0.8
(2.89)
7.7
(5.45)
500 Hz
0.8
(1.44)
6.0
(18.87)
-2.5
(3.54)
-1.7
(2.50)
9.1
(14.32)
1,000 Hz
1.7
(2.89)
1.7
(4.81)
0
(2.04)
-1.7
(1.44)
8.2
(3.83)
2,000 Hz
0.8
(2.89)
0.2
(7.27)
-0.6
(2.39)
-2.5
(4.33)
4.8
(5.66)
3,000 Hz
0
(5.00)
0.2
(4.94)
0.6
(1.25)
-7.5
(2.50)
5.1
(4.84)
4,000 Hz
-2.5
(6.61)
1.0
(3.76)
1.3
(2.50)
-0.8
(6.29)
3.3
(4.25)
6,000 Hz
-0.8
(1.44)
-0.6
(3.56)
-8.1
(11.79)
-1.7
(5.77)
3.2
(6.19)
8,000 Hz
-3.3
(5.77)
-4.2
(10.78)
-8.8
(17.50)
-0.8
(6.29)
0.8
(10.83)
7. Secondary Outcome
Title Number of Participants With Change in Brainstem Auditory Evoked Responses (BAER) Compared to Pretreatment Values
Description BAERs was assessed with standard techniques for clinically significant threshold improvements compared to baseline levels.
Time Frame 24 months

Outcome Measure Data

Analysis Population Description
PD analysis set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
8. Secondary Outcome
Title Number of Participants With Response in Vestibular Function in Treated Ear Compared to Pretreatment Values
Description Response in vestibular assessments (Head impulse test (HIT), Vestibular evoked myogenic potential (VEMP), Subjective visual vertical (SVV)) to CGF166.
Time Frame 24 months

Outcome Measure Data

Analysis Population Description
PD Analysis Set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Number of participants
Measure Participants 3 12 4 3 22
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
9. Secondary Outcome
Title 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
Description 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.
Time Frame 24 months

Outcome Measure Data

Analysis Population Description
PD analysis set
Arm/Group Title CGF166 Dose 20 μL CGF166 Dose 30 μL CGF166 Dose 40 μL CGF166 Dose 60 μL Total
Arm/Group Description single dose volume #1 single dose volume #2 single dose volume #3 single dose volume #4 Total Number of participants
Measure Participants 3 12 4 3 22
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%

Adverse Events

Time Frame Adverse events (AEs) were collected from first dose of study treatment until end of study treatment at 52 weeks
Adverse Event Reporting Description AEs are any untoward sign or symptom that occurs during the study treatment
Arm/Group Title CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Arm/Group Description CCGF166X2201 20 μL CCGF166X2201 30 μL CCGF166X2201 40 μL CCGF166X2201 60 μL
All Cause Mortality
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Serious Adverse Events
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Other (Not Including Serious) Adverse Events
CGF166 20 μL CGF166 30 μL CGF166 40 μL CGF166 60 μL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/3 (100%) 6/12 (50%) 4/4 (100%) 3/3 (100%)
Cardiac disorders
Left ventricular hypertrophy 0/3 (0%) 0/12 (0%) 0/4 (0%) 1/3 (33.3%)
Ear and labyrinth disorders
Deafness unilateral 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Ear haemorrhage 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Ear pain 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Hypoacusis 0/3 (0%) 2/12 (16.7%) 4/4 (100%) 1/3 (33.3%)
Tinnitus 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Tympanic membrane disorder 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Vertigo 1/3 (33.3%) 1/12 (8.3%) 1/4 (25%) 0/3 (0%)
Vestibular disorder 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Gastrointestinal disorders
Nausea 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
General disorders
Fatigue 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Immune system disorders
Food allergy 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Seasonal allergy 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Infections and infestations
Otitis media 0/3 (0%) 0/12 (0%) 0/4 (0%) 1/3 (33.3%)
Sinusitis 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Vestibular neuronitis 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Investigations
Electrocardiogram T wave abnormal 0/3 (0%) 0/12 (0%) 0/4 (0%) 1/3 (33.3%)
Metabolism and nutrition disorders
Gout 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Intervertebral disc protrusion 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Myalgia 0/3 (0%) 0/12 (0%) 0/4 (0%) 2/3 (66.7%)
Spinal stenosis 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Nervous system disorders
Dizziness 0/3 (0%) 2/12 (16.7%) 1/4 (25%) 1/3 (33.3%)
Dysgeusia 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Nystagmus 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Syncope 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Vestibular migraine 0/3 (0%) 0/12 (0%) 1/4 (25%) 0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Skin and subcutaneous tissue disorders
Dermal cyst 1/3 (33.3%) 0/12 (0%) 0/4 (0%) 0/3 (0%)
Dermatitis allergic 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Urticaria 0/3 (0%) 1/12 (8.3%) 0/4 (0%) 0/3 (0%)
Vascular disorders
Hypertension 0/3 (0%) 0/12 (0%) 0/4 (0%) 1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Study Director
Organization Novartis Pharmaceuticals
Phone +1 (862) 778-8300
Email novartis.email@novartis.com
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02132130
Other Study ID Numbers:
  • CCGF166X2201
First Posted:
May 7, 2014
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021