Trial Outcomes & Findings for An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies (NCT NCT03842969)
NCT ID: NCT03842969
Last Updated: 2023-08-31
Results Overview
The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
236 participants
Primary outcome timeframe
Up to Approximately 3 Years
Results posted on
2023-08-31
Participant Flow
The study consists of Period 1 and 2. All participants (17) in the Q4W arm stopped Q4W dosing (Period 1) and 15 participants continued into the two Arms of Period 2. Due to the statistical outputs available, Period 1 and 2 are reported as Milestones below. None of the participants completed the study.
Periods 1 and 2 are sequential. 15 from 17 participants from Period 1 Q4W were re-randomized to receive Tominersen 120 mg Q8W or Q16W in Period 2 randomly and blinded. .
Participant milestones
| Measure |
Tominersen 120mg Q4W
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120mg Q8W
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120mg Q16W
Participants received open-label RO7234292 Q16W in this Arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
138
|
81
|
|
Overall Study
Period 1
|
17
|
0
|
0
|
|
Overall Study
Period 2
|
0
|
146
|
88
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
138
|
81
|
Reasons for withdrawal
| Measure |
Tominersen 120mg Q4W
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120mg Q8W
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120mg Q16W
Participants received open-label RO7234292 Q16W in this Arm
|
|---|---|---|---|
|
Overall Study
Participant declined follow-up visit
|
0
|
1
|
0
|
|
Overall Study
Sponsor's decision
|
12
|
99
|
61
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
30
|
18
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
Baseline Characteristics
After Period 1, 15 patients continued to Period 2 with re-randomization
Baseline characteristics by cohort
| Measure |
Tominersen 120mg Q4W
n=17 Participants
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120mg Q8W
n=138 Participants
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120mg Q16W
n=81 Participants
Participants received open-label RO7234292 Q16W in this Arm
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Period 1
|
50.4 Years
STANDARD_DEVIATION 8.9 • n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
—
|
—
|
50.4 Years
STANDARD_DEVIATION 8.9 • n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Age, Continuous
Period 2
|
—
|
47.9 Years
STANDARD_DEVIATION 9.8 • n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
48.4 Years
STANDARD_DEVIATION 11.2 • n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
48.2 Years
STANDARD_DEVIATION 10.5 • n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Sex: Female, Male
Period 1 · Female
|
6 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
6 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Sex: Female, Male
Period 1 · Male
|
11 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
11 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Sex: Female, Male
Period 2 · Female
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
71 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
37 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
108 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Sex: Female, Male
Period 2 · Male
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
67 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
44 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
111 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 1 · Hispanic or Latino
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 1 · Not Hispanic or Latino
|
17 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
17 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 1 · Unknown or Not Reported
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 2 · Hispanic or Latino
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
13 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
7 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
20 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 2 · Not Hispanic or Latino
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
125 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
74 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
199 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Ethnicity (NIH/OMB)
Period 2 · Unknown or Not Reported
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · American Indian or Alaska Native
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · Asian
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · Black or African American
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · White
|
17 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
17 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · More than one race
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 1 · Unknown or Not Reported
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=17 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · American Indian or Alaska Native
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · Asian
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
2 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
1 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
3 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · Black or African American
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
2 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
0 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
2 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · White
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
132 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
76 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
208 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · More than one race
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
1 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
1 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
2 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
|
Race (NIH/OMB)
Period 2 · Unknown or Not Reported
|
0 Participants
After Period 1, 15 patients continued to Period 2 with re-randomization
|
1 Participants
n=138 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
3 Participants
n=81 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
4 Participants
n=219 Participants • After Period 1, 15 patients continued to Period 2 with re-randomization
|
PRIMARY outcome
Timeframe: Up to Approximately 3 YearsPopulation: Safety Population
The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake.
Outcome measures
| Measure |
Tominersen 120mg Q4W
n=14 Participants
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120 mg Q8W
n=143 Participants
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120 mg Q16W
n=88 Participants
Participants received open-label RO7234292 Q16W in this Arm
|
Tominersen 120mg Q8W (With Loading)
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q8W
|
Tominersen 120mg Q8W (Prior BP40410)
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q4W in study BP40410
|
Tominersen 120mg Q16W (Prior Q4W)
Participants received open-label RO7234292 Q16W after having received Q4W treatment previously
|
Tominersen 120mg Q16W (No Loading)
Participants received open-label RO7234292 Q16W without prior treatment with RO7234292
|
Tominersen 120mg Q16W (Prior BP40410)
Participants received open-label RO7234292 Q16W with prior treatment with RO7234292 Q4W in study BP40410
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events
|
71.4 Percentage of Participants
|
83.9 Percentage of Participants
|
81.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 3 YearsPopulation: Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) are included. All other data were not evaluable due to participants' discontinuation
C-SSRS is to assess suicidal ideation and behavior. 4 constructs measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Yes/No data collected for 10 categories, composite endpoints based on the categories are followed over time to monitor safety. Composite endpoint of suicidal ideation (1-5), n and (%) are the number and % of who experience any of the five suicidal ideation events at least once after receiving the first dose of study medication. Composite endpoint of suicidal behavior (6-10), n and (%) are the number and percent of patients who experience any 1of 5 suicidal behavior events at least 1 after receiving the 5 dose of study medication. Composite endpoint of suicidal ideation or behavior (1-10), n and (%) are the number and % of patients who experience any 1 the 10 suicidal ideation or behavior events at least once after receiving the first dose of study medication.
Outcome measures
| Measure |
Tominersen 120mg Q4W
n=14 Participants
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120 mg Q8W
n=143 Participants
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120 mg Q16W
n=88 Participants
Participants received open-label RO7234292 Q16W in this Arm
|
Tominersen 120mg Q8W (With Loading)
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q8W
|
Tominersen 120mg Q8W (Prior BP40410)
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q4W in study BP40410
|
Tominersen 120mg Q16W (Prior Q4W)
Participants received open-label RO7234292 Q16W after having received Q4W treatment previously
|
Tominersen 120mg Q16W (No Loading)
Participants received open-label RO7234292 Q16W without prior treatment with RO7234292
|
Tominersen 120mg Q16W (Prior BP40410)
Participants received open-label RO7234292 Q16W with prior treatment with RO7234292 Q4W in study BP40410
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation (1-5) -Non-specific Active Suicidal Thoughts
|
0 Number of participants
|
9 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation (1-5) -Wish to Be Dead
|
1 Number of participants
|
16 Number of participants
|
3 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation (1-5) -Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act
|
0 Number of participants
|
7 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation (1-5) -Active Suicidal Ideation with Intent to Act, without Specific Plan
|
0 Number of participants
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation (1-5) -Active Suicidal Ideation with Specific Plan and Intent
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior (6-10) -Preparatory Acts or Behavior
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior (6-10) -Aborted Attempt
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior (6-10) -Interrupted Attempt
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior (6-10) -Non-fatal Suicide Attempt
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior (6-10) -Completed Suicide
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation or Behavior (1-10)
|
1 Number of participants
|
16 Number of participants
|
3 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Self-injurious Behavior without Suicidal Intent
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Ideation
|
0 Number of participants
|
14 Number of participants
|
2 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Serious Suicidal Ideation
|
0 Number of participants
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Emergence of Serious Suicidal Ideation
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Emergence of Suicidal Behavior
|
0 Number of participants
|
3 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Approximately 3 YearsPopulation: Safety Population. Data evaluable participants were reported, all other data are not available. Only those participants who contributed and whose data were analyzed for data are reported in the table.
MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment. MOCA01-Total scores are reported. The data presented are absolute scores for baseline and change from baseline for post-baseline assessments. All Arms except Tominersen 120mg Q4W (Period 1) belong to the Milestone Period 2.
Outcome measures
| Measure |
Tominersen 120mg Q4W
n=14 Participants
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120 mg Q8W
n=25 Participants
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120 mg Q16W
n=72 Participants
Participants received open-label RO7234292 Q16W in this Arm
|
Tominersen 120mg Q8W (With Loading)
n=43 Participants
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q8W
|
Tominersen 120mg Q8W (Prior BP40410)
n=3 Participants
Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q4W in study BP40410
|
Tominersen 120mg Q16W (Prior Q4W)
n=24 Participants
Participants received open-label RO7234292 Q16W after having received Q4W treatment previously
|
Tominersen 120mg Q16W (No Loading)
n=60 Participants
Participants received open-label RO7234292 Q16W without prior treatment with RO7234292
|
Tominersen 120mg Q16W (Prior BP40410)
n=4 Participants
Participants received open-label RO7234292 Q16W with prior treatment with RO7234292 Q4W in study BP40410
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 113
|
—
|
0.18 Score of a Scale
Standard Deviation 1.94
|
-0.36 Score of a Scale
Standard Deviation 2.65
|
0.10 Score of a Scale
Standard Deviation 2.62
|
—
|
0.19 Score of a Scale
Standard Deviation 2.51
|
0.36 Score of a Scale
Standard Deviation 3.01
|
—
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 49
|
—
|
0.33 Score of a Scale
Standard Deviation 2.33
|
-0.39 Score of a Scale
Standard Deviation 2.83
|
-0.08 Score of a Scale
Standard Deviation 2.26
|
-0.67 Score of a Scale
Standard Deviation 3.06
|
-0.40 Score of a Scale
Standard Deviation 2.68
|
-0.13 Score of a Scale
Standard Deviation 2.53
|
3.00 Score of a Scale
Standard Deviation 3.46
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 65
|
—
|
-0.09 Score of a Scale
Standard Deviation 2.09
|
-0.08 Score of a Scale
Standard Deviation 2.56
|
-0.08 Score of a Scale
Standard Deviation 1.91
|
-5.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
-0.43 Score of a Scale
Standard Deviation 2.86
|
0.27 Score of a Scale
Standard Deviation 2.85
|
0.50 Score of a Scale
Standard Deviation 3.54
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 81
|
—
|
0.59 Score of a Scale
Standard Deviation 1.30
|
-0.38 Score of a Scale
Standard Deviation 3.31
|
-0.09 Score of a Scale
Standard Deviation 1.95
|
-2.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
0.25 Score of a Scale
Standard Deviation 2.57
|
-0.24 Score of a Scale
Standard Deviation 2.90
|
0.50 Score of a Scale
Standard Deviation 3.54
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 97
|
—
|
-0.47 Score of a Scale
Standard Deviation 2.06
|
-0.97 Score of a Scale
Standard Deviation 3.12
|
0.45 Score of a Scale
Standard Deviation 2.20
|
—
|
0.24 Score of a Scale
Standard Deviation 2.46
|
-0.46 Score of a Scale
Standard Deviation 3.01
|
—
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 129
|
—
|
-0.75 Score of a Scale
Standard Deviation 1.22
|
-0.50 Score of a Scale
Standard Deviation 1.95
|
-0.15 Score of a Scale
Standard Deviation 3.48
|
—
|
-0.11 Score of a Scale
Standard Deviation 1.90
|
2.20 Score of a Scale
Standard Deviation 3.19
|
—
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 145
|
—
|
0.33 Score of a Scale
Standard Deviation 1.53
|
—
|
-4.83 Score of a Scale
Standard Deviation 5.91
|
—
|
0.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
—
|
—
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Baseline
|
24.50 Score of a Scale
Standard Deviation 3.98
|
25.08 Score of a Scale
Standard Deviation 3.49
|
24.92 Score of a Scale
Standard Deviation 3.47
|
24.62 Score of a Scale
Standard Deviation 4.44
|
25.33 Score of a Scale
Standard Deviation 1.53
|
23.43 Score of a Scale
Standard Deviation 4.49
|
24.03 Score of a Scale
Standard Deviation 3.88
|
19.75 Score of a Scale
Standard Deviation 4.35
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 17
|
-4.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
0.46 Score of a Scale
Standard Deviation 2.19
|
0.16 Score of a Scale
Standard Deviation 2.58
|
0.19 Score of a Scale
Standard Deviation 2.56
|
-1.00 Score of a Scale
Standard Deviation 1.00
|
-0.57 Score of a Scale
Standard Deviation 2.01
|
-0.17 Score of a Scale
Standard Deviation 2.79
|
3.25 Score of a Scale
Standard Deviation 2.36
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 25
|
3.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)
MOCA01-Total Week 33
|
3.00 Score of a Scale
Standard Deviation NA
No data available in the range
|
0.16 Score of a Scale
Standard Deviation 1.74
|
0.28 Score of a Scale
Standard Deviation 2.61
|
0.35 Score of a Scale
Standard Deviation 1.76
|
0.67 Score of a Scale
Standard Deviation 2.08
|
-0.90 Score of a Scale
Standard Deviation 2.76
|
0.32 Score of a Scale
Standard Deviation 2.44
|
2.25 Score of a Scale
Standard Deviation 2.22
|
Adverse Events
Tominersen 120mg Q4W
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Tominersen 120 mg Q8W
Serious events: 17 serious events
Other events: 99 other events
Deaths: 0 deaths
Tominersen 120 mg Q16W
Serious events: 9 serious events
Other events: 56 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tominersen 120mg Q4W
n=14 participants at risk
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120 mg Q8W
n=143 participants at risk
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120 mg Q16W
n=88 participants at risk
Participants received open-label RO7234292 Q16W in this Arm
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
General disorders
Cyst
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
General disorders
Gait disturbance
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Infections and infestations
Abscess limb
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Chorea
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Irritability
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 3 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Surgical and medical procedures
Euthanasia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
Other adverse events
| Measure |
Tominersen 120mg Q4W
n=14 participants at risk
Participants received open-label RO7234292 Q4W in this Arm
|
Tominersen 120 mg Q8W
n=143 participants at risk
Participants received open-label RO7234292 Q8W in this Arm
|
Tominersen 120 mg Q16W
n=88 participants at risk
Participants received open-label RO7234292 Q16W in this Arm
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 2 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
6.3%
9/143 • Number of events 9 • Up to Approx. 3 Years
|
5.7%
5/88 • Number of events 6 • Up to Approx. 3 Years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 2 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
3.5%
5/143 • Number of events 5 • Up to Approx. 3 Years
|
4.5%
4/88 • Number of events 5 • Up to Approx. 3 Years
|
|
General disorders
Gait disturbance
|
0.00%
0/14 • Up to Approx. 3 Years
|
2.1%
3/143 • Number of events 4 • Up to Approx. 3 Years
|
5.7%
5/88 • Number of events 5 • Up to Approx. 3 Years
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 3 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Infections and infestations
Injection site infection
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Up to Approx. 3 Years
|
9.1%
13/143 • Number of events 15 • Up to Approx. 3 Years
|
3.4%
3/88 • Number of events 3 • Up to Approx. 3 Years
|
|
Infections and infestations
Onychomycosis
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 3 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
3.5%
5/143 • Number of events 6 • Up to Approx. 3 Years
|
4.5%
4/88 • Number of events 5 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
2/14 • Number of events 2 • Up to Approx. 3 Years
|
11.2%
16/143 • Number of events 28 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 9 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Eye contusion
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
7/14 • Number of events 50 • Up to Approx. 3 Years
|
30.8%
44/143 • Number of events 110 • Up to Approx. 3 Years
|
23.9%
21/88 • Number of events 145 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/14 • Up to Approx. 3 Years
|
7.7%
11/143 • Number of events 12 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.3%
2/14 • Number of events 2 • Up to Approx. 3 Years
|
13.3%
19/143 • Number of events 33 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 7 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.1%
1/14 • Number of events 10 • Up to Approx. 3 Years
|
4.9%
7/143 • Number of events 15 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 15 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
6.3%
9/143 • Number of events 13 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Investigations
CSF protein increased
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 3 • Up to Approx. 3 Years
|
4.5%
4/88 • Number of events 5 • Up to Approx. 3 Years
|
|
Investigations
Vitamin D decreased
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to Approx. 3 Years
|
5.6%
8/143 • Number of events 9 • Up to Approx. 3 Years
|
3.4%
3/88 • Number of events 3 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • Up to Approx. 3 Years
|
13.3%
19/143 • Number of events 24 • Up to Approx. 3 Years
|
15.9%
14/88 • Number of events 15 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
2.1%
3/143 • Number of events 3 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Nervous system disorders
Amnesia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 3 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Aphasia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
2.1%
3/143 • Number of events 3 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Nervous system disorders
Balance disorder
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
4.5%
4/88 • Number of events 4 • Up to Approx. 3 Years
|
|
Nervous system disorders
Cerebellar atrophy
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
2.8%
4/143 • Number of events 4 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Nervous system disorders
Coordination abnormal
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Up to Approx. 3 Years
|
5.6%
8/143 • Number of events 9 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Dysarthria
|
7.1%
1/14 • Number of events 2 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Extensor plantar response
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Up to Approx. 3 Years
|
9.1%
13/143 • Number of events 25 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 6 • Up to Approx. 3 Years
|
|
Nervous system disorders
Hypotonia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Memory impairment
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
2.1%
3/143 • Number of events 3 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Motor dysfunction
|
7.1%
1/14 • Number of events 2 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 3 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Parkinsonism
|
7.1%
1/14 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 3 • Up to Approx. 3 Years
|
|
Nervous system disorders
Pleocytosis
|
7.1%
1/14 • Number of events 2 • Up to Approx. 3 Years
|
5.6%
8/143 • Number of events 16 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Nervous system disorders
Post-traumatic headache
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Nervous system disorders
Restless legs syndrome
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 7 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Affect lability
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 2 • Up to Approx. 3 Years
|
0.00%
0/88 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Anxiety
|
14.3%
2/14 • Number of events 2 • Up to Approx. 3 Years
|
4.2%
6/143 • Number of events 6 • Up to Approx. 3 Years
|
8.0%
7/88 • Number of events 8 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Depressed mood
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
1.4%
2/143 • Number of events 2 • Up to Approx. 3 Years
|
2.3%
2/88 • Number of events 3 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
4.2%
6/143 • Number of events 6 • Up to Approx. 3 Years
|
4.5%
4/88 • Number of events 5 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
11.9%
17/143 • Number of events 17 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 6 • Up to Approx. 3 Years
|
|
Psychiatric disorders
Irritability
|
14.3%
2/14 • Number of events 3 • Up to Approx. 3 Years
|
2.8%
4/143 • Number of events 4 • Up to Approx. 3 Years
|
6.8%
6/88 • Number of events 8 • Up to Approx. 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 2 • Up to Approx. 3 Years
|
|
Vascular disorders
Haematoma
|
14.3%
2/14 • Number of events 2 • Up to Approx. 3 Years
|
0.70%
1/143 • Number of events 1 • Up to Approx. 3 Years
|
3.4%
3/88 • Number of events 4 • Up to Approx. 3 Years
|
|
Vascular disorders
Lymphoedema
|
7.1%
1/14 • Number of events 1 • Up to Approx. 3 Years
|
0.00%
0/143 • Up to Approx. 3 Years
|
1.1%
1/88 • Number of events 1 • Up to Approx. 3 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER