Trial Outcomes & Findings for Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (NCT NCT02809118)
NCT ID: NCT02809118
Last Updated: 2020-08-07
Results Overview
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
Day 0 and Day 91: The study was prematurely terminated.
Results posted on
2020-08-07
Participant Flow
The study was prematurely discontinued while recruitment was still low (56 out of the planned 300 subjects). Recruitment started on 16 June 2016. On 28 November 2017, recruitment was stopped. This study was conducted in USA, Canada and South Korea.
In subjects assessed within the first 24 hours from Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) onset, mean hearing threshold had to be confirmed by a second measure that was conducted, at the earliest, 24 hours after the onset of ISSNHL.
Participant milestones
| Measure |
Placebo
Placebo gel for intratympanic use
Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo gel for intratympanic use
Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo gel for intratympanic use
Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.4 mg/ml
n=19 Participants
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.8 mg/ml
n=19 Participants
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
57.7 years
STANDARD_DEVIATION 15.25 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 15.13 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 14.36 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 14.96 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 91: The study was prematurely terminated.Population: The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data.
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 and Day 91: The study was prematurely terminated.Population: The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data.
Change in WRS from Day 0 to Day 91. The WRS was determined with country-/language-specific word lists. At least 20 mono- or disyllabic words were presented in random order. After each word was presented to the subject, the subject was asked to repeat it, and to guess it, if he/she was not sure of the word. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
AM-111 0.4 mg/ml
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
AM-111 0.8 mg/ml
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo gel for intratympanic use
Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.4 mg/ml
n=19 participants at risk
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.8 mg/ml
n=19 participants at risk
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Sepsis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo gel for intratympanic use
Placebo: Placebo gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.4 mg/ml
n=19 participants at risk
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
AM-111 0.4 mg/ml: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
AM-111 0.8 mg/ml
n=19 participants at risk
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
AM-111 0.8 mg/ml: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
10.5%
2/19 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Vertigo positional
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Eustachian tube disfunction
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
10.5%
2/19 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
15.8%
3/19 • Number of events 3 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Nystagmus
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Dyspesia
|
11.1%
2/18 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Hepatitis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Hordeolum
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Asthenia
|
11.1%
2/18 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Facial pain
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Feeling hot
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Malaise
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Pyrexia
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
General disorders
Thirst
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal stiffness
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Eye disorders
Conjunctival hyperaemia
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Eye disorders
Eye pain
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Investigations
Blood glucose increased
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Blood and lymphatic system disorders
Mastocytosis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Psychiatric disorders
Depressed mood
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Psychiatric disorders
Emotional disorder
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Vascular disorders
Aortic dilation
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Congenital, familial and genetic disorders
Colour blindness
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/18 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
|
Gastrointestinal disorders
Dyspesia
|
11.1%
2/18 • Number of events 2 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
0.00%
0/19 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
5.3%
1/19 • Number of events 1 • For each participant, adverse event data were collected from day 0 to day 91(±7).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place