Trial Outcomes & Findings for Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment (NCT NCT00688376)
NCT ID: NCT00688376
Last Updated: 2022-01-05
Results Overview
TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of "Hits" (correct responses), omission errors (failure to respond), commission errors/"False Alarms" (incorrect responses), response time, and sensitivity ("d-prime"). "D-prime" a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of "d-prime" is reached by having more "Hits" (correct response) and fewer "False Alarms" (incorrect response). Analysis was based on three factors: the "d-prime" standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2022-01-05
Participant Flow
This study was conducted at 22 centers in the United States, France, Germany, the Netherlands, Spain, the UK, Argentina, Chile, and Australia during the period of 02 July 2008 to 26 May 2009.
This trial had three phases: (1)pre-randomization to establish eligibility; (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight; (3) a 12-week, blinded extension phase during which all participants received active drug. Eligible participants were randomized to receive placebo or donepezil.
Participant milestones
| Measure |
Donepezil
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Double-Blind Phase
STARTED
|
40
|
32
|
|
Double-Blind Phase
Safety Population
|
40
|
31
|
|
Double-Blind Phase
COMPLETED
|
34
|
25
|
|
Double-Blind Phase
NOT COMPLETED
|
6
|
7
|
|
Blinded Extension Phase
STARTED
|
34
|
25
|
|
Blinded Extension Phase
COMPLETED
|
29
|
20
|
|
Blinded Extension Phase
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Donepezil
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Double-Blind Phase
Adverse Event
|
4
|
4
|
|
Double-Blind Phase
Protocol Violation
|
1
|
2
|
|
Double-Blind Phase
Withdrawal by Subject
|
1
|
0
|
|
Double-Blind Phase
Not treated
|
0
|
1
|
|
Blinded Extension Phase
Adverse Event
|
3
|
4
|
|
Blinded Extension Phase
Withdrawal by Subject
|
0
|
1
|
|
Blinded Extension Phase
Physician Decision
|
1
|
0
|
|
Blinded Extension Phase
Other
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
Baseline characteristics by cohort
| Measure |
Donepezil
n=40 Participants
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
n=31 Participants
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 Years
STANDARD_DEVIATION 3.06 • n=99 Participants
|
11.6 Years
STANDARD_DEVIATION 2.83 • n=107 Participants
|
11.9 Years
STANDARD_DEVIATION 2.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT "d-prime" standard score was available at both Screening and at least one "d-prime" score from the treatment period, in addition to having a post-Baseline safety assessment.
TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of "Hits" (correct responses), omission errors (failure to respond), commission errors/"False Alarms" (incorrect responses), response time, and sensitivity ("d-prime"). "D-prime" a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of "d-prime" is reached by having more "Hits" (correct response) and fewer "False Alarms" (incorrect response). Analysis was based on three factors: the "d-prime" standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.
Outcome measures
| Measure |
Donepezil
n=39 Participants
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
n=30 Participants
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Change From Baseline in the Test of Variables in Attention-Continuous Performance Test (TOVA-CPT) "D-prime" Standard Score (SS) at Week 12
|
5.2 d-prime
Standard Deviation 8.77
|
4.5 d-prime
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one visit after the first dose of study drug during the Double-Blind Phase.
TOVA-CPT test has a standardized computer game-like format that tests attention and simple impulse control. It precisely measures a person's reaction time to clicking on correct targets versus incorrect targets. Scores are based on the number of "Hits" (correct responses), omission errors (failure to respond), commission errors/"False Alarms" (incorrect responses), response time, and sensitivity ("d-prime"). "D-prime" a dimensionless statistics is a measure of distractibility and reflects how well a person reacts correctly versus incorrectly. A higher value of "d-prime" is reached by having more "Hits" (correct response) and fewer "False Alarms" (incorrect response). Analysis was based on three factors: the "d-prime" standard score, reaction time variability standard score, and response time standard score. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.
Outcome measures
| Measure |
Donepezil
n=39 Participants
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
n=30 Participants
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Change From Baseline in the TOVA-CPT "D-prime" Standard Score (SS) at Week 6
|
5.7 d-prime
Standard Deviation 8.41
|
6.2 d-prime
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 12Population: Intent-to-Treat (ITT) Last Observed Carried Forward (LOCF) population included all safety participants for whom the TOVA-CPT d-prime standard score was available at both Screening and at least one visit after the first dose of study drug during the Double-Blind Phase.
The Reaction Time Variability is defined as the time measurement of how consistently the switch is pressed. The Response Time is the measurement of how fast or slow information is processed and responded to by the participant. The testing process was as described in a previous outcome measure. Standard scores less than or equal to 80 were significant for an attention deficit disorder. Standard scores greater than 80 were not significant for an attention deficit disorder.
Outcome measures
| Measure |
Donepezil
n=39 Participants
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
n=30 Participants
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12
RTVSS (Week 6)
|
-3.4 milliseconds
Standard Deviation 18.44
|
-3.2 milliseconds
Standard Deviation 15.75
|
|
Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12
RTVSS (Week 12)
|
-3.9 milliseconds
Standard Deviation 15.21
|
-5.0 milliseconds
Standard Deviation 17.00
|
|
Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12
RTSS (Week 6)
|
-6.9 milliseconds
Standard Deviation 13.17
|
-9.6 milliseconds
Standard Deviation 13.25
|
|
Change From Baseline in the Reaction Time Variability Standard Score (RTVSS) and Response Time Standard Score (RTSS) at Weeks 6 and 12
RTSS (Week 12)
|
-9.0 milliseconds
Standard Deviation 13.15
|
-9.1 milliseconds
Standard Deviation 12.79
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population LOCF
Behavioral Rating Inventory of Executive Functioning test evaluates impairment of executive function(planning and organization),memory,and sustained attention in children aged 5-18 years with wide range of developmental and acquired neurological conditions.Survey assess parent/guardian's perception of their child's executive functioning in home and school environments,which relate to daily function(as judged by parent).Each survey contains 86 items scored as;1(behavior is never a problem),2(behavior is sometimes a problem),or 3(behavior is often a problem).Data was presented as t-scores(raw scale scores are used to generate t-scores)for Global Executive Composite Score(t-score range 72-216),Behavioral Regulation Index(t-score range 28-84;inhibit,shift,and emotional control),Metacognition Inde (t-score range 44-132;initiate,working memory,plan/organize,organization of materials, and monitor),and Working Memory Subscale(t-score range 35-90).Higher scores indicate decline in performance.
Outcome measures
| Measure |
Donepezil
n=39 Participants
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo
n=30 Participants
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|
|
Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale
Global Executive Composite Score
|
-1.3 t-scores
Standard Deviation 6.73
|
-3.8 t-scores
Standard Deviation 6.78
|
|
Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale
Behavioral Regulation Index
|
0.8 t-scores
Standard Deviation 7.54
|
-1.9 t-scores
Standard Deviation 6.91
|
|
Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale
Metacognition Index
|
-2.3 t-scores
Standard Deviation 7.29
|
-4.9 t-scores
Standard Deviation 6.99
|
|
Change From Baseline in the Global Executive Composite Score, Behavioral Regulation Index, Metacognition Index, and Working Memory Subscale
Working Memory Scale
|
-3.6 t-scores
Standard Deviation 7.45
|
-3.3 t-scores
Standard Deviation 6.59
|
Adverse Events
Donepezil Double-Blind Phase
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo Double-Blind Phase
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Donepezil Blinded Extension Phase
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Blinded Extension Phase
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil Double-Blind Phase
n=40 participants at risk
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo Double-Blind Phase
n=31 participants at risk
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
Donepezil Blinded Extension Phase
n=34 participants at risk
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo Blinded Extension Phase
n=25 participants at risk
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
Other adverse events
| Measure |
Donepezil Double-Blind Phase
n=40 participants at risk
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo Double-Blind Phase
n=31 participants at risk
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
Donepezil Blinded Extension Phase
n=34 participants at risk
Donepezil 3 mg, 5 mg, or 10 mg donepezil Immediate Release (IR) orally, once daily
|
Placebo Blinded Extension Phase
n=25 participants at risk
Placebo, matching 3 mg, 5 mg, and 10 mg placebo tablets administered orally, once daily
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Endocrine disorders
Precocious puberty
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Eye disorders
Eye discharge
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Eye disorders
Tear discoloration
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Eye disorders
Vision blurred
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
9.7%
3/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
8.0%
2/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
12.0%
3/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
12.0%
3/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
General disorders
Asthenia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
General disorders
Chills
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
General disorders
Fatigue
|
5.0%
2/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
9.7%
3/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
General disorders
Pyrexia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
General disorders
Xerosis
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Ear infection
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Furuncle
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
9.7%
3/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Otitis media
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
8.0%
2/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Investigations
Urine analysis abnormal
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Investigations
Weight increased
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
4/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
8.0%
2/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Ataxia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Burning sensation
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
16.0%
4/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Dysgeusia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Headache
|
25.0%
10/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
22.6%
7/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
5.9%
2/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
24.0%
6/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Hyperreflexia
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Memory impairment
|
5.0%
2/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Nervous system disorder
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Abnormal behavior
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Affect lability
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Attention deficit/Hyperactivity disorder
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Mood swings
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Nightmare
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Renal and urinary disorders
Micturition urgency
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Renal and urinary disorders
Pollakiuria
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
8.0%
2/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
2.9%
1/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
3/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
6.5%
2/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
4.0%
1/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Vascular disorders
Flushing
|
0.00%
0/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
3.2%
1/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
|
Vascular disorders
Pallor
|
2.5%
1/40 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/31 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/34 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
0.00%
0/25 • For each participant, adverse events were collected from the time the participant signed the informed consent form up to 30 days after discontinuation, or approximately 203 days.
Safety population included randomized participants who received at least one dose of study medication and who had at least one post-Baseline safety assessment. Treatment-emergent adverse events (TEAEs), defined as an adverse event that started/increased in severity on/after the first dose of study medication are presented in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place