Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (NCT NCT04445831)
NCT ID: NCT04445831
Last Updated: 2025-02-14
Results Overview
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
Results posted on
2025-02-14
Participant Flow
Recruitment was performed in Finland, the Netherlands, Sweden and the UK. 79 subjects were screened for the study; 22 subjects did not meet the eligibility criteria; 1 subject was re-screened and qualified to participate.
Screening details: Subjects between 50 and 75 years at screening with Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria, providing a written informed consent and fulfilling all further inclusion criteria could enter the clinical trial.
Participant milestones
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
19
|
6
|
10
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
4
|
17
|
5
|
10
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject withdrawal by caregiver
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
37 Participants
n=6 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 5.01 • n=99 Participants
|
68.0 years
STANDARD_DEVIATION 6.29 • n=107 Participants
|
64.7 years
STANDARD_DEVIATION 4.63 • n=206 Participants
|
67.7 years
STANDARD_DEVIATION 4.60 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 6.22 • n=31 Participants
|
63.0 years
STANDARD_DEVIATION 4.77 • n=30 Participants
|
68.0 years
STANDARD_DEVIATION 6.16 • n=3 Participants
|
66.67 years
STANDARD_DEVIATION 5.54 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
27 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
56 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
57 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
14 participants
n=6 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=99 Participants
|
4 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
6 participants
n=6 Participants
|
|
Region of Enrollment
Finland
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
3 participants
n=31 Participants
|
4 participants
n=30 Participants
|
4 participants
n=3 Participants
|
32 participants
n=6 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
5 participants
n=6 Participants
|
|
Clinical Dementia Rating (CDR) - Global Score
Score = 0.5
|
6 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
50 Participants
n=6 Participants
|
|
Clinical Dementia Rating (CDR) - Global Score
Score = 1
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Concomitant Medication
Acetylcholinesterase Inhibitors and/or Memantine
|
5 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
44 Participants
n=6 Participants
|
|
Concomitant Medication
No Acetylcholinesterase Inhibitors or Memantine
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Mini Mental State Examination (MMSE) Total score
|
27.5 units on a scale
STANDARD_DEVIATION 0.84 • n=99 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 2.02 • n=107 Participants
|
26.0 units on a scale
STANDARD_DEVIATION 2.68 • n=206 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 3.11 • n=7 Participants
|
28.0 units on a scale
STANDARD_DEVIATION 1.55 • n=31 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 3.61 • n=30 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 2.52 • n=3 Participants
|
26.28 units on a scale
STANDARD_DEVIATION 2.46 • n=6 Participants
|
PRIMARY outcome
Timeframe: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included in the Safety population, which is identical to the Intention-to Treat (ITT) population (all randomized subjects who received at least one dose of the study drug).
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any TEAE with Outcome of Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any TEAE
|
6 Participants
|
17 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any Serious TEAE
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any Severe TEAE
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any Adverse Drug Reactions
|
3 Participants
|
15 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any Serious Adverse Drug Reactions
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any TEAE Leading to Study Drug Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overview of Treatment-Emergent Adverse Events, Safety Set
Any TEAE Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Between the first dosing and the last study visit (week 74)Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included.
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Mild
|
2 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Moderate
|
3 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Between the first dosing and the last study visit (week 74)Population: Observations are given for the Safety population (all randomized subjects who received at least one dose of the study drug, analyzed based on the study treatment actually received). All 57 subjects randomized in the study received at least 1 dose of the study drug according to their randomized treatment and are therefore all included.
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Unrelated
|
3 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Related
|
3 Participants
|
15 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
Change from baseline to Week 26
|
-6.00 mmHg
Standard Deviation NA
No Standard Deviation as only 1 participant analyzed
|
2.47 mmHg
Standard Deviation 8.790
|
3.67 mmHg
Standard Deviation 5.989
|
2.00 mmHg
Standard Deviation 7.578
|
-5.00 mmHg
Standard Deviation 3.795
|
-3.17 mmHg
Standard Deviation 7.627
|
-8.25 mmHg
Standard Deviation 14.500
|
|
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
Change from baseline to Week 50
|
-6.75 mmHg
Standard Deviation 2.500
|
-0.33 mmHg
Standard Deviation 6.334
|
5.20 mmHg
Standard Deviation 9.203
|
-4.20 mmHg
Standard Deviation 6.713
|
-1.83 mmHg
Standard Deviation 5.037
|
-2.50 mmHg
Standard Deviation 5.167
|
-5.00 mmHg
Standard Deviation 8.602
|
|
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
Change from baseline to Week 74
|
-3.75 mmHg
Standard Deviation 5.377
|
4.76 mmHg
Standard Deviation 8.511
|
1.60 mmHg
Standard Deviation 5.857
|
0.40 mmHg
Standard Deviation 7.412
|
-3.33 mmHg
Standard Deviation 6.947
|
-3.33 mmHg
Standard Deviation 4.227
|
-1.25 mmHg
Standard Deviation 11.325
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Change from baseline to Week 50
|
-5.25 mmHg
Standard Deviation 13.647
|
-1.83 mmHg
Standard Deviation 19.242
|
9.20 mmHg
Standard Deviation 9.859
|
-2.50 mmHg
Standard Deviation 14.393
|
1.33 mmHg
Standard Deviation 17.535
|
0.67 mmHg
Standard Deviation 5.574
|
-1.75 mmHg
Standard Deviation 23.243
|
|
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Change from baseline to Week 26
|
-15.00 mmHg
Standard Deviation NA
No Standard Deviation as only 1 participant analyzed
|
4.11 mmHg
Standard Deviation 16.773
|
9.33 mmHg
Standard Deviation 8.335
|
1.38 mmHg
Standard Deviation 11.388
|
-3.17 mmHg
Standard Deviation 9.411
|
3.50 mmHg
Standard Deviation 8.550
|
-3.75 mmHg
Standard Deviation 27.861
|
|
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Change from baseline to Week 74
|
-3.75 mmHg
Standard Deviation 15.457
|
-1.00 mmHg
Standard Deviation 19.082
|
6.60 mmHg
Standard Deviation 15.421
|
-1.60 mmHg
Standard Deviation 21.035
|
0.67 mmHg
Standard Deviation 17.014
|
-2.83 mmHg
Standard Deviation 7.195
|
3.75 mmHg
Standard Deviation 27.208
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Heart Rate, ITT Set
Change from baseline to Week 26
|
-2.00 bpm
Standard Deviation NA
No Standard Deviation as only 1 participant analyzed
|
-4.11 bpm
Standard Deviation 9.225
|
-1.17 bpm
Standard Deviation 9.948
|
-4.38 bpm
Standard Deviation 11.649
|
-1.83 bpm
Standard Deviation 7.494
|
-0.33 bpm
Standard Deviation 4.885
|
-10.00 bpm
Standard Deviation 11.888
|
|
Mean Change From Baseline in Heart Rate, ITT Set
Change from baseline to Week 74
|
2.25 bpm
Standard Deviation 6.752
|
1.41 bpm
Standard Deviation 8.675
|
-7.40 bpm
Standard Deviation 7.232
|
1.90 bpm
Standard Deviation 13.674
|
-6.17 bpm
Standard Deviation 3.920
|
-0.67 bpm
Standard Deviation 7.967
|
-10.25 bpm
Standard Deviation 14.728
|
|
Mean Change From Baseline in Heart Rate, ITT Set
Change from baseline to Week 50
|
-5.75 bpm
Standard Deviation 4.193
|
-2.61 bpm
Standard Deviation 7.935
|
-2.80 bpm
Standard Deviation 7.596
|
-0.30 bpm
Standard Deviation 9.019
|
-6.00 bpm
Standard Deviation 5.762
|
-3.00 bpm
Standard Deviation 6.633
|
-7.25 bpm
Standard Deviation 11.558
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Temperature, ITT Set
Change from baseline to Week 50
|
0.03 °C
Standard Deviation 0.299
|
0.18 °C
Standard Deviation 0.451
|
-0.04 °C
Standard Deviation 0.532
|
0.36 °C
Standard Deviation 0.357
|
-0.08 °C
Standard Deviation 0.880
|
-0.47 °C
Standard Deviation 0.266
|
0.05 °C
Standard Deviation 0.635
|
|
Mean Change From Baseline in Body Temperature, ITT Set
Change from baseline to Week 26
|
-0.40 °C
Standard Deviation NA
No Standard Deviation as only 1 participant analyzed
|
0.02 °C
Standard Deviation 0.617
|
0.03 °C
Standard Deviation 0.367
|
0.19 °C
Standard Deviation 0.360
|
0.12 °C
Standard Deviation 0.781
|
0.02 °C
Standard Deviation 0.462
|
0.30 °C
Standard Deviation 0.497
|
|
Mean Change From Baseline in Body Temperature, ITT Set
Change from baseline to Week 74
|
0.08 °C
Standard Deviation 0.171
|
0.13 °C
Standard Deviation 0.625
|
-0.18 °C
Standard Deviation 0.383
|
0.29 °C
Standard Deviation 0.623
|
0.00 °C
Standard Deviation 0.555
|
-0.35 °C
Standard Deviation 0.367
|
0.15 °C
Standard Deviation 0.436
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 50 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Baseline · No
|
6 Participants
|
19 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Baseline · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 26 · No
|
3 Participants
|
19 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 26 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 50 · No
|
4 Participants
|
18 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 74 · No
|
4 Participants
|
17 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior - Week 74 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 10 · Not evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 26 · Abnormal NCS
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 26 · Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 50 · Normal
|
4 Participants
|
17 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Baseline · Normal
|
5 Participants
|
17 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Baseline · Abnormal NCS
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Baseline · Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Baseline · Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 10 · Normal
|
6 Participants
|
16 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 10 · Abnormal NCS
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 10 · Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 26 · Normal
|
1 Participants
|
17 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 26 · Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 50 · Abnormal NCS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 50 · Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 50 · Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 74 · Normal
|
3 Participants
|
15 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 74 · Abnormal NCS
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 74 · Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal MRI Results, ITT Set
Week 74 · Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Baseline
|
2048.4 AU/mL
Interval 1155.4 to 3631.6
|
994.6 AU/mL
Interval 688.7 to 1436.5
|
676.2 AU/mL
Interval 476.0 to 960.6
|
802.4 AU/mL
Interval 713.5 to 902.2
|
913.9 AU/mL
Interval 619.4 to 1348.4
|
1073.3 AU/mL
Interval 808.9 to 1424.1
|
981.7 AU/mL
Interval 711.2 to 1354.9
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 2
|
80292.0 AU/mL
Interval 37517.3 to 171835.3
|
158154.6 AU/mL
Interval 86332.2 to 289728.2
|
187980.6 AU/mL
Interval 99157.0 to 356371.2
|
811.0 AU/mL
Interval 714.5 to 920.5
|
1403.8 AU/mL
Interval 1065.4 to 1849.6
|
5286.1 AU/mL
Interval 1053.3 to 26530.2
|
895.4 AU/mL
Interval 598.7 to 1339.2
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 8
|
49360.9 AU/mL
Interval 19121.1 to 127424.7
|
92181.7 AU/mL
Interval 56336.9 to 150833.0
|
66035.9 AU/mL
Interval 37536.0 to 116174.9
|
768.6 AU/mL
Interval 684.5 to 863.1
|
3054.4 AU/mL
Interval 1875.2 to 4975.1
|
6928.5 AU/mL
Interval 2386.1 to 20118.9
|
971.5 AU/mL
Interval 668.5 to 1412.0
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 10
|
110984.4 AU/mL
Interval 31648.6 to 389197.3
|
182111.4 AU/mL
Interval 113522.2 to 292141.7
|
135520.1 AU/mL
Interval 71679.7 to 256219.1
|
749.7 AU/mL
Interval 652.5 to 861.4
|
105042.6 AU/mL
Interval 39205.0 to 281442.5
|
82513.4 AU/mL
Interval 34350.2 to 198207.6
|
969.2 AU/mL
Interval 671.7 to 1398.6
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 24
|
6900.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
32248.7 AU/mL
Interval 19704.9 to 52777.7
|
19853.3 AU/mL
Interval 10110.8 to 38983.4
|
1056.1 AU/mL
Interval 860.3 to 1296.6
|
27519.3 AU/mL
Interval 11321.5 to 66891.5
|
27030.2 AU/mL
Interval 11647.9 to 62726.3
|
789.4 AU/mL
Interval 524.8 to 1187.3
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 26
|
21800.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
71385.3 AU/mL
Interval 43249.5 to 117824.7
|
60104.8 AU/mL
Interval 26253.5 to 137603.9
|
1136.8 AU/mL
Interval 913.4 to 1414.8
|
329361.3 AU/mL
Interval 136886.4 to 792473.2
|
123787.7 AU/mL
Interval 85919.6 to 178345.7
|
919.5 AU/mL
Interval 646.4 to 1308.0
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 36
|
8207.3 AU/mL
Interval 3347.2 to 20124.4
|
30141.2 AU/mL
Interval 17057.1 to 53261.7
|
19810.7 AU/mL
Interval 9322.3 to 42099.2
|
571.6 AU/mL
Interval 373.6 to 874.5
|
127585.6 AU/mL
Interval 64839.7 to 251051.1
|
58190.1 AU/mL
Interval 43600.4 to 77661.9
|
1245.1 AU/mL
Interval 728.7 to 2127.6
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 48
|
5408.4 AU/mL
Interval 2873.1 to 10181.1
|
17533.0 AU/mL
Interval 9904.6 to 31036.7
|
10848.2 AU/mL
Interval 4285.7 to 27459.9
|
676.2 AU/mL
Interval 523.4 to 873.7
|
56549.1 AU/mL
Interval 28051.0 to 113999.4
|
25968.2 AU/mL
Interval 18637.2 to 36182.9
|
1137.1 AU/mL
Interval 599.1 to 2158.2
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 50
|
86662.7 AU/mL
Interval 22301.9 to 336760.7
|
54164.6 AU/mL
Interval 28561.9 to 102717.6
|
63735.9 AU/mL
Interval 38946.7 to 104303.4
|
617.0 AU/mL
Interval 464.4 to 819.7
|
408403.6 AU/mL
Interval 273922.2 to 608908.1
|
137934.8 AU/mL
Interval 61731.7 to 308205.1
|
1311.8 AU/mL
Interval 750.6 to 2292.6
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 67
|
14623.7 AU/mL
Interval 7565.4 to 28267.4
|
17464.2 AU/mL
Interval 8728.8 to 34941.7
|
10128.3 AU/mL
Interval 5232.7 to 19604.1
|
714.1 AU/mL
Interval 555.9 to 917.2
|
144349.8 AU/mL
Interval 92815.9 to 224496.7
|
47764.4 AU/mL
Interval 20377.3 to 111959.5
|
681.2 AU/mL
Interval 451.3 to 1028.0
|
|
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 74
|
10527.5 AU/mL
Interval 6075.0 to 18243.5
|
15301.0 AU/mL
Interval 7889.7 to 29673.9
|
8565.4 AU/mL
Interval 3914.9 to 18740.2
|
719.1 AU/mL
Interval 577.5 to 895.5
|
107038.5 AU/mL
Interval 63784.9 to 179623.2
|
31817.4 AU/mL
Interval 11556.3 to 87601.2
|
682.9 AU/mL
Interval 468.2 to 995.9
|
PRIMARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug)
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 24
|
2770.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
9446.6 AU/mL
Interval 6001.8 to 14868.6
|
6424.4 AU/mL
Interval 2758.4 to 14962.3
|
2381.2 AU/mL
Interval 1081.9 to 5241.0
|
6235.7 AU/mL
Interval 3717.7 to 10459.3
|
5275.9 AU/mL
Interval 3016.0 to 9228.9
|
2128.9 AU/mL
Interval 923.8 to 4906.4
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Baseline
|
1553.4 AU/mL
Interval 1116.9 to 2160.5
|
2515.4 AU/mL
Interval 1449.4 to 4365.5
|
1691.8 AU/mL
Interval 862.3 to 3319.3
|
2006.5 AU/mL
Interval 1120.3 to 3593.7
|
2659.9 AU/mL
Interval 1508.2 to 4691.1
|
2027.6 AU/mL
Interval 1551.2 to 2650.4
|
2754.4 AU/mL
Interval 1696.8 to 4471.2
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 2
|
4147.0 AU/mL
Interval 1790.9 to 9602.7
|
8245.3 AU/mL
Interval 5162.3 to 13169.5
|
4132.5 AU/mL
Interval 2007.6 to 8506.3
|
2270.6 AU/mL
Interval 1276.5 to 4038.9
|
2419.2 AU/mL
Interval 1263.7 to 4631.6
|
2128.4 AU/mL
Interval 1371.1 to 3303.9
|
2680.9 AU/mL
Interval 1514.7 to 4745.2
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 8
|
4281.7 AU/mL
Interval 2522.5 to 7267.8
|
7928.5 AU/mL
Interval 5215.6 to 12052.4
|
3973.2 AU/mL
Interval 2439.9 to 6469.9
|
1992.7 AU/mL
Interval 1095.7 to 3624.2
|
2904.3 AU/mL
Interval 1461.7 to 5770.6
|
2270.4 AU/mL
Interval 1289.0 to 3999.3
|
2682.9 AU/mL
Interval 1663.9 to 4326.0
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 10
|
9371.5 AU/mL
Interval 3398.3 to 25843.8
|
17848.1 AU/mL
Interval 11623.1 to 27406.9
|
9317.6 AU/mL
Interval 5404.3 to 16064.5
|
2099.3 AU/mL
Interval 1172.8 to 3757.7
|
17874.8 AU/mL
Interval 8298.9 to 38500.1
|
13086.9 AU/mL
Interval 6317.8 to 27108.8
|
2497.6 AU/mL
Interval 1493.9 to 4175.7
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 26
|
3890.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
13142.7 AU/mL
Interval 8034.0 to 21499.9
|
8779.5 AU/mL
Interval 4383.4 to 17584.7
|
2488.8 AU/mL
Interval 1181.0 to 5244.9
|
32099.1 AU/mL
Interval 10656.3 to 96688.8
|
17640.8 AU/mL
Interval 12002.0 to 25928.7
|
2174.3 AU/mL
Interval 918.7 to 5146.0
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 36
|
2709.4 AU/mL
Interval 2188.5 to 3354.3
|
12713.9 AU/mL
Interval 7440.1 to 21726.0
|
6886.6 AU/mL
Interval 2758.6 to 17191.7
|
2358.4 AU/mL
Interval 1297.9 to 4285.5
|
14491.7 AU/mL
Interval 6314.7 to 33257.6
|
10543.9 AU/mL
Interval 7864.9 to 14135.6
|
2273.8 AU/mL
Interval 1091.3 to 4737.7
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 48
|
2287.7 AU/mL
Interval 1733.1 to 3019.9
|
9108.4 AU/mL
Interval 5469.1 to 15169.4
|
5886.6 AU/mL
Interval 2446.7 to 14162.3
|
2254.2 AU/mL
Interval 1218.0 to 4171.7
|
7237.2 AU/mL
Interval 3437.4 to 15237.7
|
6321.2 AU/mL
Interval 4670.3 to 8555.7
|
2213.5 AU/mL
Interval 969.2 to 5055.1
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 50
|
7472.5 AU/mL
Interval 3323.2 to 16802.6
|
13280.3 AU/mL
Interval 7620.5 to 23143.7
|
8536.0 AU/mL
Interval 4170.1 to 17472.6
|
2340.1 AU/mL
Interval 1268.6 to 4317.0
|
30248.2 AU/mL
Interval 12315.3 to 74294.5
|
25491.5 AU/mL
Interval 10441.9 to 62231.3
|
2436.9 AU/mL
Interval 1199.6 to 4950.6
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 67
|
3219.8 AU/mL
Interval 2578.6 to 4020.4
|
8944.8 AU/mL
Interval 5974.4 to 13392.0
|
6180.6 AU/mL
Interval 2623.0 to 14563.1
|
2080.4 AU/mL
Interval 1122.4 to 3856.0
|
13077.0 AU/mL
Interval 7162.9 to 23874.1
|
10082.0 AU/mL
Interval 4602.9 to 22083.5
|
2295.7 AU/mL
Interval 1480.2 to 3560.6
|
|
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 74
|
2791.9 AU/mL
Interval 2285.3 to 3410.8
|
8993.0 AU/mL
Interval 5314.7 to 15216.9
|
5383.9 AU/mL
Interval 2349.5 to 12337.4
|
2126.0 AU/mL
Interval 1168.7 to 3867.5
|
10835.5 AU/mL
Interval 5870.1 to 20000.8
|
6788.7 AU/mL
Interval 3017.2 to 15274.3
|
2178.8 AU/mL
Interval 1549.6 to 3063.5
|
SECONDARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug)
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 48
|
416.0 AU/mL
Interval 279.6 to 618.9
|
635.2 AU/mL
Interval 354.9 to 1136.9
|
417.1 AU/mL
Interval 212.1 to 820.1
|
243.1 AU/mL
Interval 181.6 to 325.4
|
25681.2 AU/mL
Interval 14983.1 to 44017.8
|
13486.3 AU/mL
Interval 7865.4 to 23124.1
|
282.8 AU/mL
Interval 153.1 to 522.4
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Baseline
|
374.7 AU/mL
Interval 287.3 to 488.8
|
357.1 AU/mL
Interval 238.3 to 535.2
|
355.4 AU/mL
Interval 125.2 to 1008.8
|
251.7 AU/mL
Interval 198.1 to 319.7
|
223.0 AU/mL
Interval 135.4 to 367.5
|
394.1 AU/mL
Interval 290.2 to 535.3
|
261.0 AU/mL
Interval 144.2 to 472.4
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 2
|
2609.5 AU/mL
Interval 1098.9 to 6196.6
|
8753.9 AU/mL
Interval 3767.6 to 20339.8
|
6549.6 AU/mL
Interval 1614.8 to 26564.8
|
230.4 AU/mL
Interval 186.1 to 285.1
|
744.5 AU/mL
Interval 390.0 to 1421.1
|
2657.0 AU/mL
Interval 524.4 to 13461.1
|
233.7 AU/mL
Interval 118.9 to 459.4
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 8
|
1065.0 AU/mL
Interval 512.3 to 2213.9
|
3631.9 AU/mL
Interval 1709.8 to 7714.8
|
2000.8 AU/mL
Interval 704.1 to 5685.1
|
243.1 AU/mL
Interval 192.6 to 306.7
|
2564.1 AU/mL
Interval 1753.4 to 3749.5
|
4349.6 AU/mL
Interval 1372.9 to 13780.8
|
253.3 AU/mL
Interval 132.3 to 484.9
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 10
|
1508.6 AU/mL
Interval 649.3 to 3505.4
|
4217.5 AU/mL
Interval 2120.6 to 8387.6
|
2921.6 AU/mL
Interval 1391.6 to 6133.8
|
242.5 AU/mL
Interval 208.3 to 282.4
|
84688.8 AU/mL
Interval 36848.8 to 194638.7
|
46411.7 AU/mL
Interval 23609.7 to 91235.4
|
262.8 AU/mL
Interval 106.9 to 646.4
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 24
|
578.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
1124.8 AU/mL
Interval 647.0 to 1955.5
|
851.6 AU/mL
Interval 364.5 to 1989.6
|
343.3 AU/mL
Interval 285.9 to 412.2
|
16444.7 AU/mL
Interval 6570.8 to 41155.8
|
19762.7 AU/mL
Interval 8882.8 to 43968.6
|
236.2 AU/mL
Interval 130.0 to 429.2
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 26
|
798.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
1375.2 AU/mL
Interval 980.6 to 1928.6
|
1859.0 AU/mL
Interval 867.8 to 3982.4
|
339.5 AU/mL
Interval 262.9 to 438.2
|
162241.1 AU/mL
Interval 72817.9 to 361479.1
|
74795.1 AU/mL
Interval 40734.0 to 137337.3
|
237.9 AU/mL
Interval 139.4 to 406.1
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 36
|
523.3 AU/mL
Interval 358.4 to 764.1
|
828.6 AU/mL
Interval 458.0 to 1499.1
|
806.3 AU/mL
Interval 306.5 to 2121.3
|
240.6 AU/mL
Interval 180.5 to 320.6
|
59209.8 AU/mL
Interval 35862.2 to 97757.4
|
31504.2 AU/mL
Interval 19187.4 to 51727.4
|
310.1 AU/mL
Interval 170.6 to 563.7
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 50
|
1023.0 AU/mL
Interval 594.5 to 1760.3
|
1092.4 AU/mL
Interval 595.6 to 2003.5
|
1132.9 AU/mL
Interval 472.2 to 2718.2
|
231.8 AU/mL
Interval 172.2 to 312.0
|
197833.5 AU/mL
Interval 123950.4 to 315756.0
|
70122.6 AU/mL
Interval 32136.3 to 153009.8
|
286.5 AU/mL
Interval 157.2 to 522.1
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 67
|
450.1 AU/mL
Interval 342.4 to 591.7
|
551.2 AU/mL
Interval 321.7 to 944.6
|
570.6 AU/mL
Interval 329.0 to 989.6
|
269.6 AU/mL
Interval 205.4 to 353.8
|
69607.0 AU/mL
Interval 43695.0 to 110885.3
|
32158.7 AU/mL
Interval 12000.4 to 86178.7
|
282.6 AU/mL
Interval 213.5 to 374.0
|
|
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Week 74
|
439.4 AU/mL
Interval 366.2 to 527.3
|
590.0 AU/mL
Interval 327.6 to 1062.4
|
571.9 AU/mL
Interval 334.2 to 978.6
|
253.3 AU/mL
Interval 172.3 to 372.5
|
51718.4 AU/mL
Interval 30576.2 to 87479.7
|
21920.5 AU/mL
Interval 7062.2 to 68039.9
|
267.4 AU/mL
Interval 156.3 to 457.3
|
SECONDARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 48
|
802.9 AU/mL
Interval 383.6 to 1680.4
|
1789.3 AU/mL
Interval 1318.7 to 2428.0
|
2362.7 AU/mL
Interval 1131.0 to 4935.4
|
310.9 AU/mL
Interval 173.0 to 558.5
|
368.6 AU/mL
Interval 199.9 to 679.7
|
297.6 AU/mL
Interval 91.5 to 967.3
|
278.1 AU/mL
Interval 84.2 to 919.0
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 10
|
4436.9 AU/mL
Interval 2723.2 to 7229.1
|
4792.5 AU/mL
Interval 3376.5 to 6802.3
|
7672.5 AU/mL
Interval 3433.5 to 17144.9
|
288.5 AU/mL
Interval 165.5 to 503.0
|
564.7 AU/mL
Interval 266.4 to 1197.1
|
349.6 AU/mL
Interval 139.2 to 877.8
|
225.5 AU/mL
Interval 74.3 to 684.3
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 24
|
696.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
1967.4 AU/mL
Interval 1598.0 to 2422.3
|
2758.4 AU/mL
Interval 1380.1 to 5513.0
|
345.0 AU/mL
Interval 158.5 to 750.9
|
473.9 AU/mL
Interval 215.5 to 1042.1
|
202.6 AU/mL
Interval 118.6 to 346.0
|
183.3 AU/mL
Interval 66.6 to 504.3
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 26
|
2830.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
5137.1 AU/mL
Interval 3815.8 to 6916.0
|
7950.1 AU/mL
Interval 3857.6 to 16384.4
|
334.8 AU/mL
Interval 154.6 to 725.2
|
483.3 AU/mL
Interval 213.7 to 1093.0
|
153.5 AU/mL
Interval 69.1 to 341.1
|
181.8 AU/mL
Interval 64.9 to 509.6
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 36
|
806.2 AU/mL
Interval 394.4 to 1647.9
|
2958.8 AU/mL
Interval 2148.6 to 4074.6
|
2906.2 AU/mL
Interval 1516.6 to 5569.2
|
308.2 AU/mL
Interval 168.4 to 564.0
|
356.1 AU/mL
Interval 204.2 to 621.2
|
329.0 AU/mL
Interval 143.4 to 754.5
|
265.4 AU/mL
Interval 83.0 to 848.1
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Baseline
|
355.3 AU/mL
Interval 162.5 to 777.0
|
154.8 AU/mL
Interval 113.9 to 210.4
|
368.6 AU/mL
Interval 247.9 to 547.9
|
297.5 AU/mL
Interval 166.8 to 530.6
|
337.3 AU/mL
Interval 190.5 to 597.4
|
147.1 AU/mL
Interval 50.2 to 431.4
|
248.5 AU/mL
Interval 100.0 to 617.5
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 2
|
25951.9 AU/mL
Interval 11858.8 to 56793.5
|
15563.7 AU/mL
Interval 10500.7 to 23067.8
|
20464.3 AU/mL
Interval 6475.2 to 64676.0
|
297.5 AU/mL
Interval 167.9 to 527.4
|
494.9 AU/mL
Interval 236.3 to 1036.2
|
327.4 AU/mL
Interval 100.9 to 1062.4
|
237.2 AU/mL
Interval 76.6 to 734.5
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 8
|
3666.8 AU/mL
Interval 1795.4 to 7488.6
|
3439.4 AU/mL
Interval 2477.0 to 4775.7
|
4936.6 AU/mL
Interval 1625.2 to 14994.8
|
274.9 AU/mL
Interval 158.5 to 476.8
|
476.8 AU/mL
Interval 241.0 to 943.4
|
276.8 AU/mL
Interval 108.5 to 706.1
|
217.4 AU/mL
Interval 76.7 to 615.9
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 50
|
4714.6 AU/mL
Interval 1996.9 to 11131.2
|
5214.3 AU/mL
Interval 3348.3 to 8120.3
|
8509.3 AU/mL
Interval 3839.7 to 18857.4
|
318.9 AU/mL
Interval 174.9 to 581.1
|
360.5 AU/mL
Interval 215.5 to 603.1
|
248.8 AU/mL
Interval 92.0 to 672.8
|
275.0 AU/mL
Interval 84.3 to 897.1
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 67
|
1858.5 AU/mL
Interval 879.0 to 3929.7
|
1898.6 AU/mL
Interval 1275.1 to 2827.0
|
4539.9 AU/mL
Interval 2155.0 to 9564.3
|
431.9 AU/mL
Interval 233.9 to 797.3
|
393.7 AU/mL
Interval 199.1 to 778.7
|
240.5 AU/mL
Interval 73.6 to 785.3
|
186.7 AU/mL
Interval 57.9 to 602.1
|
|
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 74
|
1785.9 AU/mL
Interval 801.8 to 3977.8
|
1509.7 AU/mL
Interval 1063.2 to 2143.7
|
3880.2 AU/mL
Interval 1741.4 to 8645.9
|
343.0 AU/mL
Interval 191.9 to 613.3
|
449.9 AU/mL
Interval 248.2 to 815.4
|
252.9 AU/mL
Interval 75.6 to 845.9
|
348.0 AU/mL
Interval 79.0 to 1533.3
|
SECONDARY outcome
Timeframe: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.Population: ITT population (i.e. all randomized subjects who received at least 1 dose of the study drug).
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Outcome measures
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 Participants
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 Participants
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 Participants
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 Participants
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Baseline
|
153.0 AU/mL
Interval 69.6 to 336.2
|
93.1 AU/mL
Interval 66.8 to 129.6
|
124.4 AU/mL
Interval 64.0 to 241.9
|
108.1 AU/mL
Interval 73.4 to 159.2
|
93.7 AU/mL
Interval 42.9 to 204.8
|
94.6 AU/mL
Interval 36.6 to 244.7
|
119.3 AU/mL
Interval 44.3 to 321.4
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 2
|
460.7 AU/mL
Interval 185.3 to 1145.2
|
449.8 AU/mL
Interval 222.5 to 909.6
|
737.8 AU/mL
Interval 121.6 to 4478.3
|
105.4 AU/mL
Interval 70.0 to 158.6
|
146.1 AU/mL
Interval 56.5 to 378.0
|
139.6 AU/mL
Interval 48.2 to 404.2
|
129.9 AU/mL
Interval 43.7 to 386.3
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 8
|
228.3 AU/mL
Interval 107.3 to 485.6
|
209.6 AU/mL
Interval 127.3 to 345.0
|
333.4 AU/mL
Interval 72.0 to 1543.1
|
98.2 AU/mL
Interval 67.3 to 143.5
|
116.8 AU/mL
Interval 53.7 to 253.8
|
101.3 AU/mL
Interval 38.4 to 267.2
|
116.5 AU/mL
Interval 44.1 to 307.8
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 10
|
220.8 AU/mL
Interval 135.4 to 360.0
|
209.5 AU/mL
Interval 133.8 to 328.0
|
409.5 AU/mL
Interval 127.0 to 1320.6
|
101.3 AU/mL
Interval 68.9 to 148.8
|
119.2 AU/mL
Interval 54.3 to 261.3
|
123.2 AU/mL
Interval 46.5 to 326.2
|
117.4 AU/mL
Interval 43.6 to 316.0
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 24
|
231.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
134.2 AU/mL
Interval 98.3 to 183.0
|
181.2 AU/mL
Interval 75.1 to 437.3
|
90.2 AU/mL
Interval 63.3 to 128.5
|
100.8 AU/mL
Interval 51.3 to 198.2
|
102.3 AU/mL
Interval 46.0 to 227.6
|
104.1 AU/mL
Interval 40.1 to 270.4
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 26
|
256.0 AU/mL
No Confidence Interval as only 1 participant analyzed
|
198.8 AU/mL
Interval 158.9 to 248.7
|
286.2 AU/mL
Interval 136.2 to 601.6
|
87.2 AU/mL
Interval 57.4 to 132.5
|
107.9 AU/mL
Interval 53.3 to 218.8
|
105.9 AU/mL
Interval 48.0 to 233.8
|
103.3 AU/mL
Interval 40.8 to 261.4
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 36
|
95.2 AU/mL
Interval 51.2 to 177.0
|
264.6 AU/mL
Interval 198.1 to 353.3
|
476.7 AU/mL
Interval 282.4 to 804.7
|
107.7 AU/mL
Interval 61.5 to 188.7
|
101.1 AU/mL
Interval 51.4 to 198.9
|
100.1 AU/mL
Interval 37.2 to 268.9
|
147.4 AU/mL
Interval 58.1 to 373.9
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 48
|
111.6 AU/mL
Interval 43.0 to 289.6
|
232.9 AU/mL
Interval 178.6 to 303.8
|
468.3 AU/mL
Interval 191.5 to 1145.1
|
120.9 AU/mL
Interval 70.7 to 206.9
|
125.8 AU/mL
Interval 67.3 to 235.1
|
133.4 AU/mL
Interval 45.6 to 390.7
|
162.6 AU/mL
Interval 62.6 to 422.4
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 50
|
171.9 AU/mL
Interval 74.8 to 395.0
|
349.2 AU/mL
Interval 270.4 to 450.9
|
507.4 AU/mL
Interval 227.5 to 1131.9
|
108.3 AU/mL
Interval 61.3 to 191.2
|
102.4 AU/mL
Interval 52.2 to 201.0
|
110.1 AU/mL
Interval 44.3 to 274.1
|
164.9 AU/mL
Interval 65.0 to 418.2
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 67
|
147.8 AU/mL
Interval 61.5 to 355.0
|
202.7 AU/mL
Interval 142.6 to 288.0
|
342.5 AU/mL
Interval 116.4 to 1007.7
|
109.7 AU/mL
Interval 70.9 to 169.6
|
93.1 AU/mL
Interval 43.0 to 201.5
|
130.9 AU/mL
Interval 49.2 to 348.2
|
144.9 AU/mL
Interval 54.7 to 384.0
|
|
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Week 74
|
144.1 AU/mL
Interval 43.4 to 478.7
|
169.1 AU/mL
Interval 121.8 to 234.6
|
329.9 AU/mL
Interval 111.9 to 972.3
|
128.2 AU/mL
Interval 90.0 to 182.6
|
108.4 AU/mL
Interval 51.4 to 228.6
|
130.6 AU/mL
Interval 49.2 to 346.3
|
161.8 AU/mL
Interval 58.5 to 447.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline up to week 74CDR-SB means Clinical Dementia Rating - Sum of Boxes. The score ranges from 0 to 18. A higher score indicates a worse outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline up to week 74RBANS means Repeatable Battery for the Assessment of Neuropsychological Status. The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline up to week 74NPI means Neuropsychiatric Inventory. The score ranges from 0 to 144. A higher score indicates a worse outcome.
Outcome measures
Outcome data not reported
Adverse Events
Sub-Cohort 1.1 (ACI-35.030 300 μg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Sub-Cohort 1.2 (ACI-35.030 900 μg)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sub-Cohort 2.1 (JACI-35.054 15 μg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sub-Cohort 2.2 (JACI-35.054 60 μg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 participants at risk
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 participants at risk
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 participants at risk
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 participants at risk
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 participants at risk
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 participants at risk
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 participants at risk
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Haemorrhagic fever with renal syndrome
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Cardiac disorders
Sinus node dysfunction
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Injection site rash
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Vascular disorders
Aneurysm thrombosis
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
Other adverse events
| Measure |
Sub-Cohort 1.1 (ACI-35.030 300 μg)
n=6 participants at risk
Subjects receiving 4 doses of ACI-35.030 300 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.2 (ACI-35.030 900 μg)
n=19 participants at risk
Subjects receiving 4 doses of ACI-35.030 900 μg at week 0, 8, 24 and 48
|
Sub-Cohort 1.3 (ACI-35.030 1800 μg)
n=6 participants at risk
Subjects receiving 4 doses of ACI-35.030 1800 μg at week 0, 8, 24 and 48
|
Cohort 1 Placebo
n=10 participants at risk
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 3 sub-cohorts 1.1, 1.2 and 1.3 (cohort 1) are pooled to represent one group. Randomization and distribution of the subjects in cohort 1 was as follows:
* Cohort 1.1: 8 patients (6 active, 2 placebo)
* Cohort 1.2: 25 patients (19 active, 6 placebo)
* Cohort 1.3: 8 patients (6 active, 2 placebo)
|
Sub-Cohort 2.1 (JACI-35.054 15 μg)
n=6 participants at risk
Subjects receiving 4 doses of JACI-35.054 15 μg at week 0, 8, 24 and 48
|
Sub-Cohort 2.2 (JACI-35.054 60 μg)
n=6 participants at risk
Subjects receiving 4 doses of JACI-35.054 60 μg at week 0, 8, 24 and 48
|
Cohort 2 Placebo
n=4 participants at risk
Subjects receiving 4 doses of placebo at week 0, 8, 24 and 48. The placebo subjects of the 2 sub cohorts 2.1 and 2.2 (cohort 2) are pooled to represent one group. Randomization and distribution of the subjects in cohort 2 was as follows:
* Cohort 2.1: 8 patients (6 active, 2 placebo)
* Cohort 2.2: 8 patients (6 active, 2 placebo)
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
73.7%
14/19 • Number of events 31 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
100.0%
6/6 • Number of events 9 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Fatigue
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
21.1%
4/19 • Number of events 4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
20.0%
2/10 • Number of events 4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
15.8%
3/19 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
50.0%
3/6 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Malaise
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.5%
2/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Chills
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Inflammation
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Oedema
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Feeling cold
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
General disorders
Feeling hot
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
36.8%
7/19 • Number of events 8 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
30.0%
3/10 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
3/6 • Number of events 4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.5%
2/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
21.1%
4/19 • Number of events 7 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
50.0%
3/6 • Number of events 7 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 7 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Balance disorder
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Postural tremor
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
15.8%
3/19 • Number of events 5 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.5%
2/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
15.8%
3/19 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.5%
2/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Behaviour disorder
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Blood iron decreased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.5%
2/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
33.3%
2/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Eye disorders
Gaze palsy
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Eye disorders
Cataract
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 2 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Metabolism and nutrition disorders
Gout
|
16.7%
1/6 • Number of events 3 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
25.0%
1/4 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
10.0%
1/10 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
5.3%
1/19 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/19 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/10 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/6 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
16.7%
1/6 • Number of events 1 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
0.00%
0/4 • The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.
Determination of Adverse Events was based on: * the signs or symptoms detected during the physical examination of the subject and on clinical assessments (e.g. laboratory values, MRI results etc.) * the interview of the subject and their caregiver
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication shall not be made by PIs before a first multi-site publication by Sponsor. If no multi-site publication is made within 18 months after study completion, PIs can publish under conditions: Prior any publication submission, PI shall send Sponsor any information to be disclosed and Sponsor have 60 days from receipt to review and comment. PI shall remove any Confidential Information and upon Sponsor request further delay publication for up to 120 days to protect Sponsor interests.
- Publication restrictions are in place
Restriction type: OTHER