Trial Outcomes & Findings for FX-322 in Adults With Acquired Sensorineural Hearing Loss (NCT NCT05086276)
NCT ID: NCT05086276
Last Updated: 2023-04-21
Results Overview
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
Baseline through Day 90
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
FX-322
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
72
|
|
Overall Study
COMPLETED
|
69
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
FX-322
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Overall Study
Missed visit 5/Day 60 visit
|
1
|
1
|
Baseline Characteristics
FX-322 in Adults With Acquired Sensorineural Hearing Loss
Baseline characteristics by cohort
| Measure |
FX-322
n=68 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 Participants
Single intratympanic injection of placebo into affected ear
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 Years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
50.6 Years
STANDARD_DEVIATION 12.20 • n=7 Participants
|
51.7 Years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
72 participants
n=7 Participants
|
140 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 90Population: Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Outcome measures
| Measure |
FX-322
n=68 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 Participants
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Word Recognition in Quiet
|
14.7 Percent of subjects
|
11.1 Percent of subjects
|
SECONDARY outcome
Timeframe: Baseline through Day 90Population: Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Mean absolute percent change in number of recognized words from CNC word lists
Outcome measures
| Measure |
FX-322
n=67 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 Participants
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Words-in-Noise
|
0.17 Percent change
Standard Deviation 2.465
|
0.35 Percent change
Standard Deviation 3.295
|
SECONDARY outcome
Timeframe: Baseline through Day 90Population: Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4 kHZ frequencies
Outcome measures
| Measure |
FX-322
n=68 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 Participants
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Standard Pure Tone Audiometry
|
65.09 Decibels (dB)
Standard Deviation 7.865
|
63.91 Decibels (dB)
Standard Deviation 9.816
|
SECONDARY outcome
Timeframe: Day 90Population: Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Average response in PGI-C hearing loss scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Outcome measures
| Measure |
FX-322
n=68 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=71 Participants
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
|
3.0 Score on a scale
Standard Deviation 0.52
|
2.9 Score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Day 90Population: Full Analysis Set is defined as all randomized subjects that met inclusion criteria who received one dose of study drug
Average response in PGI-C daily impacts scale, using the assigned numeric values of 1-5: 1) much better, 2) a little better, 3) no change, 4) a little worse 5) much worse
Outcome measures
| Measure |
FX-322
n=68 Participants
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=71 Participants
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
|
3.0 Score on a scale
Standard Deviation 0.53
|
2.8 Score on a scale
Standard Deviation 0.60
|
Adverse Events
FX-322
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FX-322
n=70 participants at risk
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 participants at risk
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Infections and infestations
Device-related infection
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extragonadal primary seminoma
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
Other adverse events
| Measure |
FX-322
n=70 participants at risk
Single intratympanic injection of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) into affected ear
|
Placebo
n=72 participants at risk
Single intratympanic injection of placebo into affected ear
|
|---|---|---|
|
Investigations
Audiogram abnormal
|
22.9%
16/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
30.6%
22/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Investigations
Blood pressure increased
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Investigations
Drug screen positive
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.4%
8/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
9.7%
7/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
3/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
4.2%
3/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
5.6%
4/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.9%
2/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
2.9%
2/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Meniere's disease
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Myringosclerosis
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Ear and labyrinth disorders
Ototoxicity
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Injection site pain
|
18.6%
13/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
9.7%
7/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Injection site scab
|
2.9%
2/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Pyrexia
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Chest pain
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Injection site discomfort
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Injection site hemorrhage
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
General disorders
Edema
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
COVID-19
|
7.1%
5/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
9.7%
7/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Bronchitis
|
2.9%
2/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
2.8%
2/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
2.8%
2/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Candida infection
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Device-related infection
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Ear injection
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Otitis media
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Pneumonia parainfluenze viral
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Rhinovirus infection
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
2.8%
2/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
2.8%
2/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
2.8%
2/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Gastrointestinal disorders
Intussusception
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Metabolism and nutrition disorders
Hyperammonemia
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Immune system disorders
Seasonal allergy
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extragonadal primary seminoma
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Psychiatric disorders
Decreased interest
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Psychiatric disorders
Depressed mood
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Psychiatric disorders
Feeling of despair
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
1.4%
1/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
0.00%
0/72 • Baseline through Day 90
Safety analysis set (SAS) is defined as subjects that received at least one dose of study drug.The SAS includes the two subjects not included in the FAS that did not meet inclusion criteria for SNHL but were dosed with drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs must obtain sponsor's written consent before publishing or presenting the trial results
- Publication restrictions are in place
Restriction type: OTHER