Trial Outcomes & Findings for Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease (NCT NCT02322021)
NCT ID: NCT02322021
Last Updated: 2021-03-05
Results Overview
A TEAE is defined as an adverse event that emerges during treatment, having been absent at pre-treatment (Baseline) or re-emerges during treatment, having been present at pre-treatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 21 months
Results posted on
2021-03-05
Participant Flow
Participants took part in the study at 30 investigative sites in the United States from 26 November 2014 to 20 December 2019.
A total of 444 participants were screened, of which 374 participants were screen failures and 70 participants were randomized and treated, out of which 43 participants completed the core phase and 41 participants entered the extension phase. No participant completed the extension phase. This study has Core Phase and an Extension Phase.
Participant milestones
| Measure |
Core Phase: Placebo
Participants with mild cognitive impairment due to alzheimer's disease (AD)/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 milligram (mg) tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
|
|---|---|---|---|---|---|
|
Core Phase
STARTED
|
17
|
17
|
19
|
17
|
0
|
|
Core Phase
COMPLETED
|
12
|
9
|
10
|
12
|
0
|
|
Core Phase
NOT COMPLETED
|
5
|
8
|
9
|
5
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
0
|
41
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
41
|
Reasons for withdrawal
| Measure |
Core Phase: Placebo
Participants with mild cognitive impairment due to alzheimer's disease (AD)/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 milligram (mg) tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Extension Phase: Elenbecestat 50 mg
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
|
|---|---|---|---|---|---|
|
Core Phase
Adverse Event
|
1
|
3
|
4
|
2
|
0
|
|
Core Phase
Participant Choice
|
4
|
5
|
4
|
2
|
0
|
|
Core Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Core Phase
Other
|
0
|
0
|
1
|
0
|
0
|
|
Extension Phase
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Extension Phase
Participant Choice
|
0
|
0
|
0
|
0
|
6
|
|
Extension Phase
Other
|
0
|
0
|
0
|
0
|
3
|
|
Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Extension Phase
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
28
|
Baseline Characteristics
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Less than or equal to (<=) 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Customized
Greater than (>) 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
A TEAE is defined as an adverse event that emerges during treatment, having been absent at pre-treatment (Baseline) or re-emerges during treatment, having been present at pre-treatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
15 Participants
|
15 Participants
|
18 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Number of Participants With Serious Adverse Events (SAEs)
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Lymphocytes
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Leukocytes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Neutrophils
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Hemoglobin
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Calcium
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Potassium
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Potassium
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Alanine Aminotransferase
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Aspartate Aminotransferase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Gamma Glutamyl Transferase
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Glucose
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Glucose
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Cholesterol
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Triglycerides
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Creatinine
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 0(Baseline,Week 2,Week 3,Week 4);Month 1(Week 5,Week 7);Month 2(Week 9,Week 11);Month 3(Week 13);Month 4(Week 17);Month 5(Week 21);Month 6(Week 27);Month 9(Week 40);Month 12(Week 53);Month 15(Week 66);Month 18(Week 79) and Follow-up at Month 1 and 3Population: The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories at given time points.
Participants having no markedly abnormal vital sign values (no markedly abnormal high or no markedly abnormal low) in all core phase arms were not included in the data reported.
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight (Month 0: Baseline)
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight (Month 3: Week 13)
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight (Follow-up: Month 3)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 0: Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 0: Week 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 5)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 1: Week 7)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 3: Week 13)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 4: Week 17)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 6: Week 27)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 9: Week 40)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 12: Week 53)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 15: Week 66)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Month 18: Week 79)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure (Follow-up: Month 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Diastolic Blood Pressure (Month 0: Week 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Diastolic Blood Pressure (Month 0: Week 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Diastolic Blood Pressure (Month 1: Week 5)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Diastolic Blood Pressure (Month 9: Week 40)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Diastolic Blood Pressure (Month 9: Week 40)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Diastolic Blood Pressure (Follow-up: Month 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight (Month 6: Week 27)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight (Month 9: Week 40)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 0: Baseline)
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 0: Week 2)
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 0: Week 3)
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 0: Week 4)
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Temperature (Month 0: Week 4)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 1: Week 5)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 1: Week 7)
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 2: Week 9)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 2: Week 11)
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 3: Week 13)
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 4: Week 17)
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 5: Week 21)
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 6: Week 27)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 9: Week 40)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 12: Week 53)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 15: Week 66)
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Month 18: Week 79)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Follow-up: Month 1)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature (Follow-up: Month 3)
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Weight (Month 0: Baseline)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the core phase and had at least 1 post-dose safety assessment.
QTcF interval means corrected QT interval (QTc) calculated using Fridericia's formula.
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
At least one post-baseline increase of >30 millisecond (msec) in QTcF interval
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
At least one post-baseline value of >450 msec in QTcF interval
|
1 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Core Phase: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
At least one post-baseline value of >480 msec in QTcF interval
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 34 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
TEAE: adverse event that emerges during treatment, having been absent at pre-treatment or reemerges during treatment, having been present at pre-treatment but stopped before treatment, or worsens in severity during treatment relative to pre-treatment state. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, regular measurement of vital signs, magnetic resonance imaging and electrocardiogram parameter values. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening (immediate risk of death from adverse event, this does not include event that, had it occurred in more severe form or is allowed to continue, might have caused death); requires inpatient or prolongation of existing hospitalization; results in persistent/significant disability/incapacity; is congenital anomaly/birth defect (in child of participant exposed to drug). Number of participants with TEAEs and SAEs were reported.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Number of Participants With TEAEs and SAEs
TEAEs
|
30 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With TEAEs and SAEs
SAEs
|
6 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 34 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Diastolic Blood Pressure
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Diastolic Blood Pressure
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Systolic Blood Pressure
|
5 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Temperature
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal Low: Temperature
|
10 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal Vital Sign Values
Markedly Abnormal High: Weight
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 34 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
QTcF interval means QTc interval calculated using Fridericia's formula.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Number of Participants With Markedly Abnormal ECG Findings
At least one post-baseline increase of >30 msec in QTcF interval
|
2 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Markedly Abnormal ECG Findings
At least one post-baseline value of >450 msec in QTcF interval
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 34 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Lymphocytes
|
4 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Neutrophils
|
2 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Hemoglobin
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Potassium
|
4 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Alanine Aminotransferase
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Gamma Glutamyl Transferase
|
2 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Glucose
|
3 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Triglycerides
|
2 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Creatinine
|
4 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal High: Urate
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values
Markedly Abnormal Low: Platelets
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 34 monthsPopulation: The safety analysis set was the group of participants who received at least 1 dose of study drug in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories.
Brain MRIs are collected to assess for potential drug-related changes that might have constituted a safety concern. Safety brain MRI is assessed using a standardized procedure that included fluid-attenuated inversion recovery (FLAIR), gradient-echo, T1, and diffusion-weighted sequences to determine the presence of focal lesions including, but not limited to, evidence for ischemic and hemorrhagic stroke, subdural hematoma, neoplasm, arteriovenous malformation, micro and macrohemorrhages, superficial siderosis, lacunar infarcts, white matter abnormalities, and vasogenic edema. Participants with abnormal values related to safety brain MRI were reported.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain Vasogenic Edema
|
0 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain Microhemorrhages
|
4 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain White Matter Disease: Focal Lesions
|
25 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Brain White Matter Disease: No Lesions
|
2 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Area of superficial siderosis
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Space occupying lesion (extra axial): Meningioma
|
1 Participants
|
—
|
—
|
—
|
|
Extension Phase: Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) Findings
Other pituitary lesion
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1 (Week 5) and Month 18 (Week 79)Population: The pharmacodynamic (PD) analysis set was the group of participants who had a baseline PD measurement and at least 1 post-dose PD measurement in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for specific categories and timepoints.
The measurement of the amyloid proteins Abeta(1-x) and Abeta(1-42), in CSF have been shown to be important biomarkers for alzheimer's disease.
Outcome measures
| Measure |
Core Phase: Placebo
n=4 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=7 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=6 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=6 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Percent Change from Baseline in CSF Abeta(1-x) at Month 1 (Week 5)
|
6.63 percent change
Standard Deviation 12.545
|
-18.16 percent change
Standard Deviation 17.873
|
-36.43 percent change
Standard Deviation 16.026
|
-56.66 percent change
Standard Deviation 14.431
|
|
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Percent Change from Baseline in CSF Abeta(1-x) at Month 18 (Week 79)
|
-1.81 percent change
Standard Deviation NA
Standard deviation could not be calculated due to only one participant was analyzed.
|
-33.86 percent change
Standard Deviation 11.039
|
-0.71 percent change
Standard Deviation NA
Standard deviation could not be calculated due to only one participant was analyzed.
|
33.98 percent change
Standard Deviation 160.017
|
|
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Percent Change from Baseline in CSF Abeta(1-42) at Month 1 (Week 5)
|
-8.53 percent change
Standard Deviation 16.818
|
-9.43 percent change
Standard Deviation 22.798
|
-20.69 percent change
Standard Deviation 15.488
|
-38.89 percent change
Standard Deviation 16.378
|
|
Core Phase: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid (A) Beta(1-x) and Abeta(1-42) After 1 Month and 18 Months of Treatment
Percent Change from Baseline in CSF Abeta(1-42) at Month 18 (Week 79)
|
-6.50 percent change
Standard Deviation 24.809
|
-27.19 percent change
Standard Deviation 20.172
|
-24.02 percent change
Standard Deviation 19.949
|
-56.77 percent change
Standard Deviation 5.312
|
SECONDARY outcome
Timeframe: Month 1 (Week 5) and Month 18 (Week 79)Population: The pharmacokinetic (PK) analysis set was the group of participants with at least 1 quantifiable elenbecestat plasma concentration accompanied by a documented dosing history in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Core Phase: Placebo
n=7 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=6 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=6 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Mean Concentration of Elenbecestat in CSF
Month 1 (Week 5)
|
1.10 nanogram per milliliter (ng/mL)
Standard Deviation 0.438
|
3.71 nanogram per milliliter (ng/mL)
Standard Deviation 1.360
|
9.93 nanogram per milliliter (ng/mL)
Standard Deviation 3.568
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in CSF
Month 18 (Week 79)
|
0.10 nanogram per milliliter (ng/mL)
Standard Deviation 0
|
2.72 nanogram per milliliter (ng/mL)
Standard Deviation 3.197
|
14.46 nanogram per milliliter (ng/mL)
Standard Deviation 3.411
|
—
|
SECONDARY outcome
Timeframe: Month 0 (Week 3), Month 3 (Week 13), Month 6 (Week 27), Month 12 (Week 53): Pre-dose, 1 to 6 hours Post-dose; Month 1 (Week 5), Month 18 (Week 79): Pre-dose, 4 to 8 hours Post-dosePopulation: The PK analysis set was the group of participants with at least 1 quantifiable elenbecestat plasma concentration accompanied by a documented dosing history in the core phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
Outcome measures
| Measure |
Core Phase: Placebo
n=17 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=19 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=16 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 1 (Week 5): 4 to 8 hours Post-dose
|
4.80 ng/mL
Standard Deviation 2.529
|
19.59 ng/mL
Standard Deviation 7.940
|
66.83 ng/mL
Standard Deviation 21.370
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 0 (Week 3): Pre-dose
|
1.43 ng/mL
Standard Deviation 1.105
|
5.81 ng/mL
Standard Deviation 3.785
|
15.77 ng/mL
Standard Deviation 11.281
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 0 (Week 3): 1 to 6 hours Post-dose
|
4.28 ng/mL
Standard Deviation 3.185
|
18.49 ng/mL
Standard Deviation 11.272
|
70.41 ng/mL
Standard Deviation 37.681
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 1 (Week 5): Pre-dose
|
1.47 ng/mL
Standard Deviation 0.870
|
6.74 ng/mL
Standard Deviation 4.246
|
15.46 ng/mL
Standard Deviation 10.463
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 3 (Week 13): Pre-dose
|
1.91 ng/mL
Standard Deviation 1.703
|
6.90 ng/mL
Standard Deviation 8.126
|
12.31 ng/mL
Standard Deviation 7.007
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 3 (Week 13): 1 to 6 hours Post-dose
|
6.06 ng/mL
Standard Deviation 2.456
|
20.35 ng/mL
Standard Deviation 8.893
|
75.15 ng/mL
Standard Deviation 27.852
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 6 (Week 27): Pre-dose
|
2.34 ng/mL
Standard Deviation 2.196
|
9.10 ng/mL
Standard Deviation 9.018
|
12.03 ng/mL
Standard Deviation 8.962
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 6 (Week 27): 1 to 6 hours Post-dose
|
11.11 ng/mL
Standard Deviation 15.322
|
25.49 ng/mL
Standard Deviation 22.247
|
71.28 ng/mL
Standard Deviation 39.114
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 12 (Week 53): Pre-dose
|
13.84 ng/mL
Standard Deviation 18.482
|
21.03 ng/mL
Standard Deviation 30.897
|
16.74 ng/mL
Standard Deviation 22.804
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 12 (Week 53): 1 to 6 hours Post-dose
|
49.78 ng/mL
Standard Deviation 40.656
|
58.38 ng/mL
Standard Deviation 65.148
|
82.55 ng/mL
Standard Deviation 56.084
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 18 (Week 79): Pre-dose
|
7.88 ng/mL
Standard Deviation 5.896
|
7.13 ng/mL
Standard Deviation 6.990
|
19.21 ng/mL
Standard Deviation 13.602
|
—
|
|
Core Phase: Mean Concentration of Elenbecestat in Plasma
Month 18 (Week 79): 4 to 8 hours Post-dose
|
47.16 ng/mL
Standard Deviation 28.651
|
51.99 ng/mL
Standard Deviation 44.656
|
70.43 ng/mL
Standard Deviation 22.500
|
—
|
SECONDARY outcome
Timeframe: Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
MMSE is a 30-point scale that measures orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. Scores ranges from 0 (most impaired) to 30 (no impairment). Lower score indicates more impairment.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Baseline
|
21.5 score on a scale
Standard Deviation 5.67
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 3
|
-0.6 score on a scale
Standard Deviation 2.32
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 6
|
-0.6 score on a scale
Standard Deviation 2.39
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 9
|
-0.9 score on a scale
Standard Deviation 2.89
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 12
|
-1.4 score on a scale
Standard Deviation 2.43
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 15
|
-1.8 score on a scale
Standard Deviation 2.78
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 18
|
-1.7 score on a scale
Standard Deviation 3.01
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 21
|
-2.5 score on a scale
Standard Deviation 3.27
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 24
|
-3.9 score on a scale
Standard Deviation 4.46
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 28
|
-6.4 score on a scale
Standard Deviation 4.28
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Mini-Mental State Examination (MMSE) Scores
Change at Month 32
|
-2.0 score on a scale
Standard Deviation NA
Standard deviation could not be calculated due to only one participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at Month 3, at Month 6, at Month 9, at Month 12, at Month 15, at Month 18, at Month 21, at Month 24, at Month 28 and at Month 32Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
The FAQ has 10 items concerned with performing daily tasks necessary for independent living. The caregiver or informant provides performance ratings on 10 complex activities of daily living performed within the preceding 4 weeks. Score ranges from 0 (independent) to 30 (dependent). Lower score indicates that participant can live independently. Higher score indicates that participant cannot live independently.
Outcome measures
| Measure |
Core Phase: Placebo
n=41 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Baseline
|
14.4 score on a scale
Standard Deviation 7.31
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 3
|
1.3 score on a scale
Standard Deviation 5.51
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 6
|
1.4 score on a scale
Standard Deviation 3.74
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 9
|
2.2 score on a scale
Standard Deviation 4.33
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 12
|
2.6 score on a scale
Standard Deviation 4.86
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 15
|
3.0 score on a scale
Standard Deviation 5.17
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 18
|
3.4 score on a scale
Standard Deviation 4.83
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 21
|
3.0 score on a scale
Standard Deviation 3.88
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 24
|
6.8 score on a scale
Standard Deviation 5.92
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 28
|
9.2 score on a scale
Standard Deviation 4.67
|
—
|
—
|
—
|
|
Extension Phase: Change From Extension Phase Baseline in the Functional Assessment Questionnaire (FAQ) Score
Change at Month 32
|
15.0 score on a scale
Standard Deviation NA
Standard deviation could not be calculated due to only one participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12 and Month 24Population: The PD analysis set was the group of participants who had at least 1 post-treatment PD measurement in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.
The measurement of the amyloid protein Abeta(1-x), in plasma has been shown to be an important biomarker for alzheimer's disease.
Outcome measures
| Measure |
Core Phase: Placebo
n=27 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
Percent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 12
|
-71.8 percent change
Standard Deviation 23.30
|
—
|
—
|
—
|
|
Extension Phase: Percent Change From Extension Phase Baseline in Plasma Amyloid (A) Beta(1-x) Measurements at Months 12 and 24
Percent Change from Extension Phase Baseline in plasma Abeta(1-x) at Month 24
|
-71.1 percent change
Standard Deviation 31.20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Total hippocampal volume is measured by volumetric magnetic resonance imaging (vMRI). Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total hippocampal volume is calculated by summing up right and left hippocampal volumes.
Outcome measures
| Measure |
Core Phase: Placebo
n=12 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Percent Change From Extension Phase Baseline in Total Hippocampal Volume at Month 24
|
-4.33 percent change
Standard Deviation 2.080
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Left and right hippocampal volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Left and right hippocampal volumes represent a summary measure in the left and right hippocampal regions.
Outcome measures
| Measure |
Core Phase: Placebo
n=12 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Percent Change at Month 24 (Left Hippocampal Volume)
|
-4.31 percent change
Standard Deviation 2.065
|
—
|
—
|
—
|
|
Extension Phase: Percent Change From Extension Phase Baseline in Left and Right Hippocampal Volume at Month 24
Percent Change at Month 24 (Right Hippocampal Volume)
|
-4.37 percent change
Standard Deviation 2.667
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Whole brain volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Whole brain volume represents a summary measure of total brain parenchyma which includes the cerebrum, basal ganglia, diencephalon, and cerebellum.
Outcome measures
| Measure |
Core Phase: Placebo
n=12 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Percent Change From Extension Phase Baseline in Whole Brain Volume at Month 24
|
-3.26 percent change
Standard Deviation 1.555
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 24Population: The full analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment in the extension phase. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Total Ventricular Volume is measured by vMRI. Volumetric imaging is a 3D technique where all the MRI signals are collected from the entire tissue sample and imaged as a whole entity, therefore providing a high signal to noise ratio. Total ventricular volume represents a summary measure of total including right and left lateral ventricles, third ventricle and fourth ventricle of brain.
Outcome measures
| Measure |
Core Phase: Placebo
n=12 Participants
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
|---|---|---|---|---|
|
Extension Phase: Percent Change From Extension Phase Baseline in Total Ventricular Volume at Month 24
|
15.18 percent change
Standard Deviation 8.544
|
—
|
—
|
—
|
Adverse Events
Core Phase: Placebo
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Core Phase: Elenbecestat 5 mg Then 50 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Core Phase: Elenbecestat 15 mg Then 50 mg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Core Phase: Elenbecestat 50 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Extension Phase: Elenbecestat 50 mg
Serious events: 6 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Core Phase: Placebo
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Extension Phase: Elenbecestat 50 mg
n=41 participants at risk
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Localised infection
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Affective disorder
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Chest pain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Delusion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Asthenia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Wound Infection
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
Other adverse events
| Measure |
Core Phase: Placebo
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received two elenbecestat matched-placebo tablets, orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat matched-placebo in core phase.
|
Core Phase: Elenbecestat 5 mg Then 50 mg
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received one elenbecestat 5 mg tablet and one elenbecestat-matched placebo tablet (to maintain blinding), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 15 mg Then 50 mg
n=19 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 15 mg (one 10 mg and one 5 mg tablets), orally, once daily with food up to 18 months. Participants who remained on treatment were reassigned to elenbecestat 50 mg (two 25 mg tablets) if they had at least 3 months (12 weeks) of treatment remaining in the randomization phase (treatment and follow-up), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Core Phase: Elenbecestat 50 mg
n=17 participants at risk
Participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD received elenbecestat 50 mg (two 25 mg tablets), orally, once daily with food up to 18 months. Participants who completed 18 months treatment or who discontinued taking study drug prematurely were followed up to 3 months (12 weeks) after last dose of elenbecestat in core phase.
|
Extension Phase: Elenbecestat 50 mg
n=41 participants at risk
Eligible participants with mild cognitive impairment due to AD/prodromal AD and mild to moderate AD who completed the core phase entered the extension phase and received one elenbecestat 50 mg tablet, orally, once daily with or without food until early discontinuation of study drug or early termination of the study, whichever occurred first. Participants were followed up to 3 months (12 weeks) after last dose of elenbecestat in extension phase.
|
|---|---|---|---|---|---|
|
Investigations
Temperature Perception Test Decreased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Transaminases Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Urinary Casts
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Weight Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Weight Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Heart Valve Incompetence
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Heart Valve Stenosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Right Ventricular Enlargement
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Eye disorders
Dry Eye
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Eye disorders
Ocular Rosacea
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Eye disorders
Visual Impairment
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Anal Incontinence
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Colitis Microscopic
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Peritoneal Disorder
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Asthenia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Breast Complication Associated With Device
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Fatigue
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
15.8%
3/19 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Gait Disturbance
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Peripheral Swelling
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Furuncle
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Gastroenteritis Viral
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Scrotal Infection
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Tooth Abscess
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
23.5%
4/17 • Number of events 6 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
23.5%
4/17 • Number of events 4 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
23.5%
4/17 • Number of events 6 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Urinary Tract Infection
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 4 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
7.3%
3/41 • Number of events 5 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
9.8%
4/41 • Number of events 5 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
B-Lymphocyte Count Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Bacterial Test Positive
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Calcium Decreased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Glucose Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Immunoglobulin G Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Potassium Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Pressure Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Blood Sodium Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Cd4 Lymphocytes Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Cd8 Lymphocytes Decreased
|
11.8%
2/17 • Number of events 4 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Monocyte Count Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Neurological Examination Abnormal
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Olfactory Test Abnormal
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Primitive Reflex Test Positive
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Respiratory Rate Increased
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Romberg Test Positive
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Cerebellar Microhaemorrhage
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Cerebral Microhaemorrhage
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 4 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Decreased Vibratory Sense
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dementia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Disturbance In Attention
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
15.8%
3/19 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
15.8%
3/19 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Hypokinesia
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Nystagmus
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Superficial Siderosis Of Central Nervous System
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Vasogenic Cerebral Oedema
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 4 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
12.2%
5/41 • Number of events 6 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
7.3%
3/41 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Hallucination, Visual
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Hypersexuality
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
9.8%
4/41 • Number of events 5 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Nightmare
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Rapid Eye Movement Sleep Behaviour Disorder
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Thinking Abnormal
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
7.3%
3/41 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Congestion
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Turbinate Hypertrophy
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Thickening
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
10.5%
2/19 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
17.6%
3/17 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
7.3%
3/41 • Number of events 3 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Erythematotelangiectatic Rosacea
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Surgical and medical procedures
Rhinoplasty
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Surgical and medical procedures
Tooth Extraction
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Vascular disorders
Aortic Arteriosclerosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.3%
1/19 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
5.9%
1/17 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/41 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Endocrine disorders
Thyroid Cyst
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Eye disorders
Cataract
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Gastrointestinal disorders
Ulcerative Gastritis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
General disorders
Propulsive Gait
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Gastritis Bacterial
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Otitis Media
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Product Administration Error
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Occult Blood Positive
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Investigations
Prostatic Specific Antigen Increased
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Coordination Abnormal
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Postural Tremor
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Delusion
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cyst
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
4.9%
2/41 • Number of events 2 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Surgical and medical procedures
Cataract Operation
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/19 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
0.00%
0/17 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
2.4%
1/41 • Number of events 1 • Up to 55 months (Core Phase: Up to 21 months; Extension Phase: Up to 34 months)
Adverse events were collected for all the participants who were in the safety analysis set. The safety analysis set was the group of participants who received at least 1 dose of study drug (Core and Extension Phase) and had at least 1 post-dose safety assessment (only Core Phase).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place