Trial Outcomes & Findings for A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (NCT NCT04491006)
NCT ID: NCT04491006
Last Updated: 2023-06-12
Results Overview
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
At Baseline (Day 1)
Results posted on
2023-06-12
Participant Flow
The study was conducted at a total of 6 centers in Australia and 8 centers in the United States (US).
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study comparing ATH-1017 40 milligrams per day (mg/day) and ATH-1017 70 mg/day with placebo in participants with a clinical diagnosis of mild to moderate Alzheimer's disease (AD).
Participant milestones
| Measure |
Placebo
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
26
|
|
Overall Study
COMPLETED
|
23
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
Baseline Characteristics
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 mg
n=27 Participants
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=26 Participants
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.0 Years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
70.6 Years
STANDARD_DEVIATION 6.54 • n=7 Participants
|
73.4 Years
STANDARD_DEVIATION 7.26 • n=5 Participants
|
71.4 Years
STANDARD_DEVIATION 7.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Baseline (Day 1)Population: Modified Intent-to-Treat (mITT) Population: included all randomized participants who took at least one dose of the study medication and who completed at least one ERP P300 Baseline assessment and/or one post-Baseline ERP P300 assessment.
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 mg
n=26 Participants
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=25 Participants
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Event-related Potential (ERP) P300 Latency at Baseline
|
361.5 Milliseconds (ms)
Standard Deviation 32.23
|
382.3 Milliseconds (ms)
Standard Deviation 40.18
|
375.3 Milliseconds (ms)
Standard Deviation 35.77
|
SECONDARY outcome
Timeframe: At Baseline (Day 1)Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 mg
n=25 Participants
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=25 Participants
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
|
23.0 Scores on a scale
Standard Deviation 7.96
|
22.4 Scores on a scale
Standard Deviation 8.94
|
20.7 Scores on a scale
Standard Deviation 7.18
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
ATH-1017 40 mg
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
ATH-1017 70 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 mg
n=27 participants at risk
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=26 participants at risk
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 mg
n=27 participants at risk
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=26 participants at risk
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.7%
2/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.1%
3/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Agitation
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Confusional state
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Blood glucose increased
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Intraocular pressure increased
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Investigations
White blood cell count increased
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Infections and infestations
Ear infection
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Infections and infestations
Respiratory tract infection
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Vascular disorders
Flushing
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Cardiac disorders
Bradycardia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.7%
2/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.7%
2/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
14.8%
4/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site reaction
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
63.0%
17/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
80.8%
21/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site vesicles
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
14.8%
4/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.1%
3/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site induration
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site nodule
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.5%
3/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site bruising
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site erythema
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site pruritus
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site mass
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site oedema
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Injection site rash
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Fatigue
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
14.8%
4/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Chest pain
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Pain
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Flushing
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Hot flush
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Induration
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Immediate post-injection reaction
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Application site pruritus
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
General disorders
Feeling abnormal
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
14.8%
4/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.7%
2/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.5%
3/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dizziness postural
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.1%
3/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Extensor plantar response
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Hyporeflexia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dysdiadochokinesis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Facial paralysis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
22.2%
6/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
19.2%
5/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.7%
2/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
2/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
11.5%
3/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Eye disorders
Blepharitis
|
4.2%
1/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
7.4%
2/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.8%
1/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/24 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
3.7%
1/27 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
0.00%
0/26 • Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER