Trial Outcomes & Findings for A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies (NCT NCT02594124)
NCT ID: NCT02594124
Last Updated: 2024-10-22
Results Overview
AE:unfavorable and unintended sign, symptom, or disease temporally associated with study/use of an investigational drug, whether or not it's considered related to investigational drug. SAE:AE that in view of either Investigator/Sponsor, meets any of the following criteria: results in death;is life-threatening:i.e.poses risk of death, hospitalization/it's prolongation;results in a persistent or significant incapacity or substantial disruption of normal life functions;results in congenital anomaly or birth defect in offspring;is an important event in the opinion of Investigator/Sponsor. TEAE: if it was present prior to first dose of nusinersen or first sham procedure in index study and subsequently worsened in severity/was not present prior to first dose of nusinersen or first sham procedure in index study but subsequently appeared.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
292 participants
Primary outcome timeframe
From Day 1 up to the end of the study (up to 2848 days)
Results posted on
2024-10-22
Participant Flow
Participants were enrolled at the investigative sites in Australia, Belgium, Canada, Germany, Spain, France, United Kingdom, Hong Kong, Italy, Japan, Republic of Korea, Sweden, Turkey, and the United States from 04 November 2015 to 21 August 2023.
A total of 292 participants with infantile and later onset spinal muscular atrophy (SMA) who previously participated in ISIS 396443-CS3B\[NCT02193074\], ISIS 396443-CS4\[NCT02292537\], ISIS 396443-CS3A\[NCT01839656\], ISIS 396443-CS12\[NCT02052791\] and 232SM202\[NCT02462759\] were enrolled and treated in this study.
Participant milestones
| Measure |
Infantile SMA Onset CS3A
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, intrathecal (IT) injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in Modified Maintenance Dosing Regimen (MMDR) period of this study.
|
Infantile SMA Onset CS3B Previous Control
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
24
|
65
|
12
|
20
|
25
|
42
|
83
|
8
|
|
Overall Study
COMPLETED
|
10
|
10
|
42
|
7
|
12
|
20
|
19
|
44
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
14
|
23
|
5
|
8
|
5
|
23
|
39
|
3
|
Reasons for withdrawal
| Measure |
Infantile SMA Onset CS3A
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, intrathecal (IT) injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in Modified Maintenance Dosing Regimen (MMDR) period of this study.
|
Infantile SMA Onset CS3B Previous Control
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
8
|
1
|
0
|
0
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
5
|
1
|
8
|
4
|
13
|
19
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Commercial drug
|
0
|
1
|
6
|
3
|
0
|
0
|
7
|
11
|
2
|
|
Overall Study
Reason Not Specified
|
1
|
3
|
4
|
0
|
0
|
1
|
1
|
6
|
1
|
Baseline Characteristics
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
Baseline characteristics by cohort
| Measure |
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
|
Age, Customized
Children (2-11 years)
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
83 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
187 Participants
n=42 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
156 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
136 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
69 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
232 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
204 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
AE:unfavorable and unintended sign, symptom, or disease temporally associated with study/use of an investigational drug, whether or not it's considered related to investigational drug. SAE:AE that in view of either Investigator/Sponsor, meets any of the following criteria: results in death;is life-threatening:i.e.poses risk of death, hospitalization/it's prolongation;results in a persistent or significant incapacity or substantial disruption of normal life functions;results in congenital anomaly or birth defect in offspring;is an important event in the opinion of Investigator/Sponsor. TEAE: if it was present prior to first dose of nusinersen or first sham procedure in index study and subsequently worsened in severity/was not present prior to first dose of nusinersen or first sham procedure in index study but subsequently appeared.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
8 Participants
|
13 Participants
|
24 Participants
|
65 Participants
|
12 Participants
|
20 Participants
|
25 Participants
|
42 Participants
|
80 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
5 Participants
|
11 Participants
|
23 Participants
|
59 Participants
|
9 Participants
|
12 Participants
|
6 Participants
|
26 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
The vital sign assessments included blood pressure, temperature, pulse rate, and respiratory rate. Participants with abnormalities in these assessments recorded as AEs were reported.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Bradycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Tachycardia
|
0 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Pyrexia
|
5 Participants
|
13 Participants
|
15 Participants
|
50 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
21 Participants
|
39 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Body Temperature Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Heart Rate Increased
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Oxygen Saturation Decreased
|
0 Participants
|
1 Participants
|
9 Participants
|
20 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Respiratory Rate Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as AEs
Tachypnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. '
Weight decrease was characterized by a decrease of \>=7% from baseline and weight increase was characterized by an increase of \>=7% from baseline. Participants with these abnormalities recorded as AEs were reported.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Weight Abnormalities Reported as AEs
Weight Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Weight Abnormalities Reported as AEs
Weight Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Participants with abnormalities in neurological examinations recorded as AEs were reported.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Tremor
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Areflexia
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Hyporeflexia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Nystagmus
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Motor Dysfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Muscle Contractions Involuntary
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Myoclonus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Neurological Abnormalities Reported as AEs
Paraesthesia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Bandaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Haematuria
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Anaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Leukocytosis
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Leukopenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Lymphopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Neutrophilia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Pancytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Thrombocytosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypertransaminasaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Pyuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Urinary Tract Infection
|
1 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Alanine Aminotransferase Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Aspartate Aminotransferase Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Albumin Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Bicarbonate Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Calcium Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Osmolarity Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Potassium Abnormal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Potassium Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Blood Potassium Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Crystal Urine Present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Full Blood Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Full Blood Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Gamma-Glutamyltransferase Increased
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Haemoglobin Decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hepatic Enzyme Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Liver Function Test Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Mean Platelet Volume Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Neutrophil Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Neutrophil Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Platelet Count Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Platelet Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Protein Urine Present
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Red Blood Cell Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Transaminases Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Urine Ketone Body Present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
White Blood Cell Count Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
White Blood Cells Urine
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
White Blood Cells Urine Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypercalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hyperglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypernatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypocalcaemia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypochloraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypoglycaemia
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hypokalaemia
|
0 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Hyponatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Electrolyte Imbalance
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Bilirubinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Ketonuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Leukocyturia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Reported as AEs
Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Coagulation parameters included activated partial thromboplastin time (aPTT) and international normalized ratio (INR). Participants with abnormalities in these coagulation parameters recorded as AEs were reported.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Coagulation Parameters Reported as AEs
Activated Partial Thromboplastin Time Prolonged
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Coagulation Parameters Reported as AEs
International Normalised Ratio Abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Coagulation Parameters Reported as AEs
International Normalised Ratio Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Coagulation Parameters Reported as AEs
Coagulopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Number analyzed' signifies number of participants evaluable for this outcome measure.
Clinical significance of abnormalities in 12 lead ECG was determined based on the investigator's discretion.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Shifts in12 Lead Electrocardiogram (ECG) Results
|
0 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to the end of the study (up to 2848 days)Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
A concomitant therapy is any non-protocol-specified drug or substance (including over-the-counter medications, herbal medications, and vitamin supplements) administered between the beginning of screening and the last telephone contact or study visit.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Taking Any Concomitant Medication
|
8 Participants
|
13 Participants
|
24 Participants
|
65 Participants
|
12 Participants
|
20 Participants
|
25 Participants
|
42 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: MMDR Period: At Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
The WHO motor milestones are a set of six milestones in motor development, all of which would be expected to be attained by 24 months of age in healthy children. The individual milestones are: sitting without support, standing with assistance, hands and knees crawling, walking with assistance, standing alone and walking alone. Mean of number of new milestones achieved was calculated and reported in this outcome measure.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=9 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=10 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=43 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=12 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=18 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=19 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=45 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Number of New Motor Milestones Achieved as Assessed by World Health Organization (WHO) Criteria
|
-0.2 motor milestone
Standard Deviation 0.75
|
0.4 motor milestone
Standard Deviation 0.73
|
0.0 motor milestone
Standard Deviation 0.00
|
0.7 motor milestone
Standard Deviation 1.15
|
0.0 motor milestone
Standard Deviation 0.53
|
-0.6 motor milestone
Standard Deviation 0.79
|
-0.1 motor milestone
Standard Deviation 0.73
|
-0.1 motor milestone
Standard Deviation 0.32
|
-0.2 motor milestone
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: At Day 309Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. Only CS3A and CS3B arm groups were planned to be analyzed for this outcome measure (OM).
HINE is evaluated in infants between 2-24 months of age. It's a simple, standardized instrument including 26 items assessing different aspects of neurological examinations, such as cranial nerves, posture, movements, tone, and reflexes. In this study, Module 2 of HINE (HINE-2) was assessed, which evaluates 8 developmental milestones (head control, sitting, voluntary grasp, ability to kick, rolling, crawling, standing, and walking) scored on a 3, 4, or 5-point scale, with 0 indicating inability to perform task and score of 2, 3, or 4 indicating full milestone development. Total score is calculated by summing item scores to give maximum possible score of 26. Higher score indicates good neurological function.
Outcome measures
| Measure |
Later SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=62 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Walking: Bouncing
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Head Control: Unable to Maintain Head Upright
|
—
|
13 percentage of participants
|
86 percentage of participants
|
34 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Head Control: Wobbles
|
—
|
13 percentage of participants
|
9 percentage of participants
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Head Control: All the Time Maintained Upright
|
—
|
75 percentage of participants
|
5 percentage of participants
|
48 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Sitting: Cannot Sit
|
—
|
13 percentage of participants
|
100 percentage of participants
|
39 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Sits With Support at Hips
|
—
|
13 percentage of participants
|
0 percentage of participants
|
19 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Sitting: Props
|
—
|
0 percentage of participants
|
0 percentage of participants
|
8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Sitting: Stable sit
|
—
|
13 percentage of participants
|
0 percentage of participants
|
19 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Sitting: Pivots (rotates)
|
—
|
63 percentage of participants
|
0 percentage of participants
|
15 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Ability to Kick: No kicking
|
—
|
0 percentage of participants
|
68 percentage of participants
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Ability to Kick: Kick horizontally legs do not lift
|
—
|
13 percentage of participants
|
32 percentage of participants
|
29 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Ability to Kick: Upward (vertically)
|
—
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Ability to Kick: Touches leg
|
—
|
0 percentage of participants
|
0 percentage of participants
|
11 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Ability to Kick: Touches toes
|
—
|
88 percentage of participants
|
0 percentage of participants
|
32 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Rolling: No Rolling
|
—
|
25 percentage of participants
|
91 percentage of participants
|
27 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Rolling: Rolling to Side
|
—
|
0 percentage of participants
|
9 percentage of participants
|
37 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Rolling: Prone to Supine
|
—
|
13 percentage of participants
|
0 percentage of participants
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Rolling: Supine to Prone
|
—
|
63 percentage of participants
|
0 percentage of participants
|
31 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Crawling: Does not Lift Head
|
—
|
63 percentage of participants
|
100 percentage of participants
|
81 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Crawling: On Elbow
|
—
|
0 percentage of participants
|
0 percentage of participants
|
13 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Crawling: On Outstretched Hand
|
—
|
0 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Crawling: Crawling Flat on Abdomen
|
—
|
13 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Crawling: Crawling on Hands and Knees
|
—
|
25 percentage of participants
|
0 percentage of participants
|
2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Standing: Does not support weight
|
—
|
38 percentage of participants
|
100 percentage of participants
|
79 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Standing: Supports weight
|
—
|
13 percentage of participants
|
0 percentage of participants
|
11 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Standing: Stands with support
|
—
|
25 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Standing: Stands unaided
|
—
|
25 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Walking: No Walking
|
—
|
75 percentage of participants
|
100 percentage of participants
|
95 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Walking: Cruising (Walks Holding on)
|
—
|
13 percentage of participants
|
0 percentage of participants
|
5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Walking: Walking Independently
|
—
|
13 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Voluntary Grasp:No Grasp
|
—
|
0 percentage of participants
|
14 percentage of participants
|
6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Voluntary Grasp:Uses Whole Hand
|
—
|
0 percentage of participants
|
55 percentage of participants
|
18 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Voluntary Grasp:Index Finger&Thumb;Immature Grasp
|
—
|
0 percentage of participants
|
14 percentage of participants
|
21 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
Voluntary Grasp:Pincer Grasp
|
—
|
100 percentage of participants
|
18 percentage of participants
|
52 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MMDR Period: Up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Permanent ventilation was defined as tracheostomy or \>=16 hours of ventilator support per day continuously for \>21 days in the absence of an acute reversible event.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=25 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=42 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=83 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=8 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=12 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died or Met Permanent Ventilation
|
0 Participants
|
0 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: MMDR Period: Up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Permanent ventilation was defined as tracheostomy or \>=16 hours of ventilator support per day continuously for \>21 days in the absence of an acute reversible event.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=42 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=83 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=25 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Not Requiring Permanent Ventilation
|
8 Participants
|
13 Participants
|
20 Participants
|
61 Participants
|
11 Participants
|
20 Participants
|
42 Participants
|
83 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 2198Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified time point. Only CS3A and CS3B arm groups were planned to be analyzed for this OM.
The CHOP INTEND test is designed to evaluate the motor skills of infants with significant motor weakness, including infants with SMA. Participants who are ≥2 years will be continued to be assessed until a CHOP INTEND maximum score of 64 is achieved. It includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning.
Outcome measures
| Measure |
Later SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Motor Function Scale
Baseline
|
—
|
47.4 score on scale
Standard Deviation 13.09
|
17.3 score on scale
Standard Deviation 9.71
|
38.8 score on scale
Standard Deviation 9.43
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Motor Function Scale
Change at Day 2198
|
—
|
-6.0 score on scale
Standard Deviation NA
Since only one participant was evaluable at Day 2198, the standard deviation (SD) could not be estimated.
|
11.5 score on scale
Standard Deviation 12.21
|
4.7 score on scale
Standard Deviation 14.18
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MMDR Period: Baseline, MMDR Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
The HFMSE consists of 33 scored activities used to assess motor function in children with SMA. Participants were asked to do a specific activity (such as rolling) and they were then graded on the quality and execution of that movement on a scale of 0=being unable, 1=performed with some compensation, and 2=unaided. The overall score is the sum of the scores for all activities with a maximum achievable score of 66. Higher scores indicate increased motor function.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=17 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=49 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=23 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=81 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score
Baseline
|
24.5 score on scale
Standard Deviation 12.64
|
14.5 score on scale
Standard Deviation 13.75
|
0.0 score on scale
Standard Deviation 0.0
|
7.3 score on scale
Standard Deviation 6.88
|
6.8 score on scale
Standard Deviation 6.06
|
25.6 score on scale
Standard Deviation 14.23
|
53.6 score on scale
Standard Deviation 8.24
|
21.1 score on scale
Standard Deviation 7.75
|
26.1 score on scale
Standard Deviation 10.99
|
|
Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score
Change at MMDR Day 1800
|
-1.2 score on scale
Standard Deviation 9.83
|
3.4 score on scale
Standard Deviation 5.93
|
0.4 score on scale
Standard Deviation 0.88
|
6.0 score on scale
Standard Deviation 9.12
|
-2.3 score on scale
Standard Deviation 3.37
|
-7.0 score on scale
Standard Deviation 6.03
|
-2.4 score on scale
Standard Deviation 3.41
|
-4.7 score on scale
Standard Deviation 7.20
|
-6.2 score on scale
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: MMDR Period: Baseline, MMDR Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
RULM Test is used in participants with SMA to assess upper limb functional ability items and has total of 20 items with an entry item that serves as functional class identification and does not contribute to total score. Remaining 19 scorable items reflect different functional domains and graded on 3-point system with score of 0 (unable), 1 (able, with modification), and 2 (able, no difficulty). There is only 1 item that is scored as a can/cannot score, with 1 as the highest score. Scorable items are summed for total score (0-37), higher scores indicating increased upper limb function. Positive change from baseline indicates improvement.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=11 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=6 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=18 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=11 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=18 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=80 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Revised Upper Limb Module (RULM) Total Score
Baseline
|
21.4 score on scale
Standard Deviation 8.60
|
11.8 score on scale
Standard Deviation 7.24
|
1.7 score on scale
Standard Deviation 1.63
|
10.3 score on scale
Standard Deviation 6.05
|
7.6 score on scale
Standard Deviation 6.23
|
24.1 score on scale
Standard Deviation 6.14
|
35.9 score on scale
Standard Deviation 1.91
|
21.1 score on scale
Standard Deviation 4.26
|
23.9 score on scale
Standard Deviation 5.69
|
|
Change From Baseline in Revised Upper Limb Module (RULM) Total Score
Change at MMDR Day 1800
|
3.2 score on scale
Standard Deviation 2.71
|
9.1 score on scale
Standard Deviation 4.70
|
0.7 score on scale
Standard Deviation 0.58
|
10.0 score on scale
Standard Deviation 5.38
|
3.3 score on scale
Standard Deviation 5.01
|
0.4 score on scale
Standard Deviation 3.23
|
0.9 score on scale
Standard Deviation 1.76
|
2.4 score on scale
Standard Deviation 3.97
|
1.2 score on scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Baseline, Day 2670Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. Only CS12 Type 2 and CS12 Type 3 arm groups were planned to be analysed for this end point.
The 6MWT measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Outcome measures
| Measure |
Later SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=1 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=13 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Distance Walked Over Time as Assessed by 6-Minute Walk Test (6MWT)
Baseline
|
—
|
0 meters
Standard Deviation NA
Due to 1 evaluable participant, SD was not estimated
|
253.3 meters
Standard Deviation 182.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Distance Walked Over Time as Assessed by 6-Minute Walk Test (6MWT)
Change at Day 2670
|
—
|
156.5 meters
Standard Deviation NA
Due to 1 evaluable participant, SD was not estimated
|
91.5 meters
Standard Deviation 49.07
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: MMDR Period: At MMDR Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Contracture assessment is performed to assess the motor performance in SMA. The number of participants who experienced at least one contracture at any location and severe contractures in any of the five locations (hip flexors, knee flexors, ankle planter flexors, elbow flexors, forearm flexors) are reported in this outcome measure.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=5 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=10 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=10 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=41 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=18 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=20 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=45 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Contracture Assesment
At least one contracture at any location
|
5 Participants
|
9 Participants
|
10 Participants
|
36 Participants
|
8 Participants
|
13 Participants
|
8 Participants
|
19 Participants
|
44 Participants
|
|
Number of Participants Who Experienced Contracture Assesment
Severe contractures in any of the five locations
|
2 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
9 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: MMDR Period: Baseline, MMDR Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. Peroneal amplitude (PA) and ulnar amplitude (UA) data is reported in this OM. Score \<0 indicated worse response and \>0 indicated better response than the normal matched population. Score change \<0 indicated worsening and \>0 indicated improvement as compared to baseline.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=60 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=23 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=33 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=62 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Compound Muscular Action Potential (CMAP)
PA: Baseline
|
1.35 millivolt (mV)
Standard Deviation 0.948
|
3.02 millivolt (mV)
Standard Deviation 2.207
|
0.35 millivolt (mV)
Standard Deviation 0.517
|
1.91 millivolt (mV)
Standard Deviation 1.367
|
0.94 millivolt (mV)
Standard Deviation 0.929
|
1.89 millivolt (mV)
Standard Deviation 1.369
|
2.71 millivolt (mV)
Standard Deviation 1.318
|
2.00 millivolt (mV)
Standard Deviation 2.189
|
1.97 millivolt (mV)
Standard Deviation 1.586
|
|
Change From Baseline in Compound Muscular Action Potential (CMAP)
PA: Change at MMDR Day 1800
|
0.10 millivolt (mV)
Standard Deviation 1.414
|
-0.41 millivolt (mV)
Standard Deviation 1.290
|
0.10 millivolt (mV)
Standard Deviation 0.243
|
0.30 millivolt (mV)
Standard Deviation 1.395
|
0.92 millivolt (mV)
Standard Deviation 1.901
|
-0.59 millivolt (mV)
Standard Deviation 1.069
|
-0.08 millivolt (mV)
Standard Deviation 1.799
|
0.22 millivolt (mV)
Standard Deviation 4.832
|
-0.28 millivolt (mV)
Standard Deviation 0.924
|
|
Change From Baseline in Compound Muscular Action Potential (CMAP)
UA: Baseline
|
1.25 millivolt (mV)
Standard Deviation 0.935
|
1.52 millivolt (mV)
Standard Deviation 1.563
|
0.20 millivolt (mV)
Standard Deviation 0.205
|
0.85 millivolt (mV)
Standard Deviation 0.944
|
0.99 millivolt (mV)
Standard Deviation 0.861
|
2.81 millivolt (mV)
Standard Deviation 1.723
|
6.76 millivolt (mV)
Standard Deviation 2.448
|
1.69 millivolt (mV)
Standard Deviation 1.133
|
2.71 millivolt (mV)
Standard Deviation 2.161
|
|
Change From Baseline in Compound Muscular Action Potential (CMAP)
UA: Change at MMDR Day 1800
|
2.77 millivolt (mV)
Standard Deviation 2.729
|
0.45 millivolt (mV)
Standard Deviation 0.837
|
0.20 millivolt (mV)
Standard Deviation 0.188
|
0.67 millivolt (mV)
Standard Deviation 1.261
|
0.15 millivolt (mV)
Standard Deviation 0.436
|
0.04 millivolt (mV)
Standard Deviation 0.957
|
0.04 millivolt (mV)
Standard Deviation 1.641
|
0.32 millivolt (mV)
Standard Deviation 1.127
|
0.52 millivolt (mV)
Standard Deviation 1.600
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Participants were analyzed for change in growth parameter of body length to evaluate clinical efficacy. The body length was calculated using either WHO or Centers for Disease Control and Prevention (CDC) scales. The CDC scale allows to calculate the body length up to 20 years, while the WHO scale allows to calculate it only up to 10 years.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=2 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=4 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=7 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=14 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=4 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=1 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=8 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=23 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Length
|
-10.3 centimeters (cm)
Standard Deviation 57.63
|
24.2 centimeters (cm)
Standard Deviation 2.86
|
19.9 centimeters (cm)
Standard Deviation 6.99
|
29.4 centimeters (cm)
Standard Deviation 6.38
|
18.8 centimeters (cm)
Standard Deviation 10.92
|
18.8 centimeters (cm)
Standard Deviation 8.54
|
23.1 centimeters (cm)
Standard Deviation 0
|
23.7 centimeters (cm)
Standard Deviation 7.06
|
24.6 centimeters (cm)
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Participants were analyzed for change in growth parameter of weight to evaluate clinical efficacy. The weight was calculated using either WHO or CDC scales. The CDC scale allows to calculate the weight up to 20 years, while the WHO scale allows to calculate it only up to 10 years.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=9 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=11 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=43 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=20 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=50 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weight
|
11.7 kilograms (kg)
Standard Deviation 8.09
|
9.8 kilograms (kg)
Standard Deviation 3.48
|
7.7 kilograms (kg)
Standard Deviation 4.39
|
9.3 kilograms (kg)
Standard Deviation 3.25
|
9.5 kilograms (kg)
Standard Deviation 7.04
|
15.1 kilograms (kg)
Standard Deviation 5.96
|
13.8 kilograms (kg)
Standard Deviation 14.88
|
15.4 kilograms (kg)
Standard Deviation 8.05
|
15.2 kilograms (kg)
Standard Deviation 7.38
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Participants who were below the age of 36 months were analyzed for change in growth parameter of weight for age to evaluate clinical efficacy. The weight for age percentile was calculated using either WHO or CDC scales. The CDC scale allows to calculate the weight for age percentile up to 20 years, while the WHO scale allows to calculate it only up to 10 years.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=11 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=43 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=9 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=14 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weight for Age Percentile
|
4.0 percentile
Standard Deviation 33.11
|
5.7 percentile
Standard Deviation 27.30
|
-5.3 percentile
Standard Deviation 28.97
|
0.3 percentile
Standard Deviation 28.55
|
-0.7 percentile
Standard Deviation 25.32
|
—
|
—
|
0.9 percentile
Standard Deviation 17.22
|
20.2 percentile
Standard Deviation 28.15
|
SECONDARY outcome
Timeframe: MMDR Period: At Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A participant was defined as a responder if they had a peroneal amplitude ≥1 mV at last visit (including the amplitude ≥1 mV at baseline and also demonstrated as such at last visit).
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=60 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=24 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=81 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of CMAP Responders
|
25 percentage of responders
|
85 percentage of responders
|
0 percentage of responders
|
72 percentage of responders
|
33 percentage of responders
|
65 percentage of responders
|
67 percentage of responders
|
60 percentage of responders
|
51 percentage of responders
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Motor milestones were measured based on WHO criteria. The WHO motor milestones are a set of six milestones in motor development, all of which would be expected to be attained by 24 months of age in healthy children. The individual milestones are: sitting without support (SWS), standing with assistance (SWA), hands and knees crawling (HKC), and walking alone (WA).
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=12 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=60 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=24 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=81 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved Motor Milestones
SWS:Achieved at Baseline&Maintained to Last Visit
|
5 Participants
|
5 Participants
|
0 Participants
|
16 Participants
|
3 Participants
|
13 Participants
|
23 Participants
|
27 Participants
|
58 Participants
|
|
Number of Participants Who Achieved Motor Milestones
SWS:Inability at Baseline, Achieved at Last visit
|
0 Participants
|
3 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Motor Milestones
HKC:Achieved at Baseline&Maintained to Last Visit
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
20 Participants
|
3 Participants
|
18 Participants
|
|
Number of Participants Who Achieved Motor Milestones
HKC: Inability at Baseline, Achieved at Last Visit
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Achieved Motor Milestones
SWA:Achieved at Baseline&Maintained to Last Visit
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
20 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Achieved Motor Milestones
SWA:Inability at Baseline, Achieved at Last Visit
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Motor Milestones
WA: Achieved at Baseline&Maintained to Last Visit
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
16 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Achieved Motor Milestones
WA: Inability at Baseline, Achieved at Last Visit
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Motor milestones were measured based on WHO criteria. The WHO motor milestones are a set of six milestones in motor development, all of which would be expected to be attained by 24 months of age in healthy children. The individual milestones are: SWS, SWA, HKC, WWA, WA and standing alone (SA). SA and WWA were assessed in this outcome measure.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=12 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=60 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=24 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=81 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved Standing Alone and Walking With Assistance
SA: Achieved at Baseline & Maintained to Last Visit
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Achieved Standing Alone and Walking With Assistance
SA: Inability at Baseline, Achieved at Last Visit
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Achieved Standing Alone and Walking With Assistance
WWA: Achieved at Baseline & Maintained to Last Visit
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Who Achieved Standing Alone and Walking With Assistance
WWA: Inability at Baseline, Achieved at Last Visit
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to day 2520Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
Total number of hospitalizations is total number of serious events that occurred during study for all participants under each group. For a participant with multiple SAEs which started at the same date and led to hospitalization, it is counted as one hospitalization.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 1-360
|
0 number of hospitalizations
|
2 number of hospitalizations
|
12 number of hospitalizations
|
30 number of hospitalizations
|
2 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
2 number of hospitalizations
|
0 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 361-720
|
0 number of hospitalizations
|
2 number of hospitalizations
|
13 number of hospitalizations
|
18 number of hospitalizations
|
1 number of hospitalizations
|
1 number of hospitalizations
|
0 number of hospitalizations
|
2 number of hospitalizations
|
1 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 721-1080
|
0 number of hospitalizations
|
0 number of hospitalizations
|
15 number of hospitalizations
|
12 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
1 number of hospitalizations
|
2 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 1081-1440
|
0 number of hospitalizations
|
1 number of hospitalizations
|
0 number of hospitalizations
|
4 number of hospitalizations
|
1 number of hospitalizations
|
1 number of hospitalizations
|
0 number of hospitalizations
|
1 number of hospitalizations
|
1 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 1441-1800
|
0 number of hospitalizations
|
2 number of hospitalizations
|
2 number of hospitalizations
|
2 number of hospitalizations
|
2 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
3 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 1801-2160
|
0 number of hospitalizations
|
1 number of hospitalizations
|
1 number of hospitalizations
|
7 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
1 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Respiratory Events
Day 2161-2520
|
—
|
0 number of hospitalizations
|
0 number of hospitalizations
|
1 number of hospitalizations
|
—
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
SECONDARY outcome
Timeframe: Up to day 2520Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
Total number of hospitalizations is total number of serious events that occurred during study for all participants under each group. For a participant with multiple SAEs which started at the same date and led to hospitalization, it is counted as one hospitalization.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 1-360
|
3 number of hospitalizations
|
6 number of hospitalizations
|
26 number of hospitalizations
|
89 number of hospitalizations
|
12 number of hospitalizations
|
2 number of hospitalizations
|
0 number of hospitalizations
|
10 number of hospitalizations
|
8 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 361-720
|
2 number of hospitalizations
|
6 number of hospitalizations
|
19 number of hospitalizations
|
64 number of hospitalizations
|
4 number of hospitalizations
|
7 number of hospitalizations
|
2 number of hospitalizations
|
10 number of hospitalizations
|
12 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 721-1080
|
1 number of hospitalizations
|
5 number of hospitalizations
|
29 number of hospitalizations
|
63 number of hospitalizations
|
7 number of hospitalizations
|
2 number of hospitalizations
|
0 number of hospitalizations
|
21 number of hospitalizations
|
21 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 1081-1440
|
3 number of hospitalizations
|
2 number of hospitalizations
|
10 number of hospitalizations
|
36 number of hospitalizations
|
4 number of hospitalizations
|
5 number of hospitalizations
|
1 number of hospitalizations
|
6 number of hospitalizations
|
10 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 1441-1800
|
0 number of hospitalizations
|
4 number of hospitalizations
|
10 number of hospitalizations
|
19 number of hospitalizations
|
3 number of hospitalizations
|
3 number of hospitalizations
|
0 number of hospitalizations
|
5 number of hospitalizations
|
18 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 1801-2160
|
0 number of hospitalizations
|
1 number of hospitalizations
|
8 number of hospitalizations
|
32 number of hospitalizations
|
0 number of hospitalizations
|
2 number of hospitalizations
|
2 number of hospitalizations
|
6 number of hospitalizations
|
13 number of hospitalizations
|
|
Total Number of Hospitalizations Due to Serious Adverse Events
Day 2161-2520
|
—
|
0 number of hospitalizations
|
1 number of hospitalizations
|
14 number of hospitalizations
|
—
|
0 number of hospitalizations
|
0 number of hospitalizations
|
1 number of hospitalizations
|
2 number of hospitalizations
|
SECONDARY outcome
Timeframe: Upto day 2160Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=22 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=60 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=24 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=81 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Time in Hospitalization
Day 1441-1800
|
0.00 percentage of days
Interval 0.0 to 1.7
|
0.00 percentage of days
Interval 0.0 to 8.3
|
0.00 percentage of days
Interval 0.0 to 20.2
|
0.00 percentage of days
Interval 0.0 to 22.6
|
0.00 percentage of days
Interval 0.0 to 12.1
|
0.00 percentage of days
Interval 0.0 to 2.0
|
0.00 percentage of days
Interval 0.0 to 0.8
|
0.00 percentage of days
Interval 0.0 to 5.3
|
0.00 percentage of days
Interval 0.0 to 8.9
|
|
Percent of Time in Hospitalization
Day 1-360
|
0.0 percentage of days
Interval 0.0 to 2.8
|
0.00 percentage of days
Interval 0.0 to 2.0
|
1.11 percentage of days
Interval 0.0 to 16.7
|
0.28 percentage of days
Interval 0.0 to 22.8
|
0.28 percentage of days
Interval 0.0 to 11.4
|
0.00 percentage of days
Interval 0.0 to 2.5
|
0.00 percentage of days
Interval 0.0 to 0.8
|
0.00 percentage of days
Interval 0.0 to 4.4
|
0.00 percentage of days
Interval 0.0 to 6.4
|
|
Percent of Time in Hospitalization
Day 361-720
|
0.0 percentage of days
Interval 0.0 to 2.5
|
0.28 percentage of days
Interval 0.0 to 4.7
|
2.08 percentage of days
Interval 0.0 to 17.2
|
0.56 percentage of days
Interval 0.0 to 19.2
|
0.00 percentage of days
Interval 0.0 to 7.8
|
0.00 percentage of days
Interval 0.0 to 3.1
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 10.3
|
0.00 percentage of days
Interval 0.0 to 29.7
|
|
Percent of Time in Hospitalization
Day 721-1080
|
0.0 percentage of days
Interval 0.0 to 11.4
|
0.00 percentage of days
Interval 0.0 to 1.7
|
0.00 percentage of days
Interval 0.0 to 7.5
|
0.00 percentage of days
Interval 0.0 to 31.3
|
0.00 percentage of days
Interval 0.0 to 20.3
|
0.00 percentage of days
Interval 0.0 to 6.1
|
0.00 percentage of days
Interval 0.0 to 1.4
|
0.00 percentage of days
Interval 0.0 to 3.6
|
0.00 percentage of days
Interval 0.0 to 12.2
|
|
Percent of Time in Hospitalization
Day 1081-1440
|
0.69 percentage of days
Interval 0.0 to 1.9
|
0.00 percentage of days
Interval 0.0 to 0.8
|
0.00 percentage of days
Interval 0.0 to 7.5
|
0.00 percentage of days
Interval 0.0 to 9.7
|
0.00 percentage of days
Interval 0.0 to 48.6
|
0.00 percentage of days
Interval 0.0 to 1.9
|
0.00 percentage of days
Interval 0.0 to 0.8
|
0.00 percentage of days
Interval 0.0 to 5.8
|
0.00 percentage of days
Interval 0.0 to 35.3
|
|
Percent of Time in Hospitalization
Day 1801-2160
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
0.00 percentage of days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: MMDR Period: Baseline, MMDR Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define scoliosis.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=5 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=11 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=42 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=12 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=10 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=35 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=67 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Cobb-Angle on X-Ray of the Thoracolumbar Spine by Visit
Baseline
|
33.0 degree
Standard Deviation 16.94
|
22.7 degree
Standard Deviation 17.86
|
16.6 degree
Standard Deviation 13.38
|
34.8 degree
Standard Deviation 18.43
|
49.2 degree
Standard Deviation 13.19
|
38.5 degree
Standard Deviation 27.36
|
29.8 degree
Standard Deviation 25.09
|
24.3 degree
Standard Deviation 19.08
|
26.8 degree
Standard Deviation 20.33
|
|
Change From Baseline in Cobb-Angle on X-Ray of the Thoracolumbar Spine by Visit
Change at MMDR day 1800
|
-13.8 degree
Standard Deviation 0
|
29.8 degree
Standard Deviation 9.46
|
16.9 degree
Standard Deviation 27.27
|
13.0 degree
Standard Deviation 29.91
|
-11.6 degree
Standard Deviation 24.65
|
-3.8 degree
Standard Deviation 17.01
|
4.0 degree
Standard Deviation 7.78
|
19.8 degree
Standard Deviation 30.83
|
18.8 degree
Standard Deviation 30.30
|
SECONDARY outcome
Timeframe: MMDR Period: At Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
Items on the PedsQL generic core scale are reverse scored and transformed to a 0-100 scale. The PedsQL parent (P) and self (S) reported questionnaire was collected for participants from 2 to 25 years of age. Four dimensions were collected: Physical, Emotional, Social and School functioning and each item was scored on a 5 point ordinal scale. 0 (never) =100, 1 (almost never) = 75, 2 (sometimes)= 50, 3 (often) = 25, 4 (almost always) = 0. A total score was calculated as the sum of all the items over the number of items answered on all the scales. If more than 50% of items or more were missing, the scale score was not computed. Higher scores indicated better health related quality of life.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=11 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=42 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=7 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=11 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=20 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=50 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
S: Physical Functioning Report
|
53.7 score on scale
Standard Deviation 24.46
|
37.1 score on scale
Standard Deviation 11.26
|
22.4 score on scale
Standard Deviation 31.52
|
47.5 score on scale
Standard Deviation 25.31
|
32.6 score on scale
Standard Deviation 20.48
|
37.5 score on scale
Standard Deviation 13.68
|
52.7 score on scale
Standard Deviation 16.94
|
45.4 score on scale
Standard Deviation 13.85
|
39.7 score on scale
Standard Deviation 17.97
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
S: Emotional Functioning Report
|
67.0 score on scale
Standard Deviation 16.43
|
61.9 score on scale
Standard Deviation 12.52
|
61.7 score on scale
Standard Deviation 26.39
|
63.3 score on scale
Standard Deviation 20.71
|
67.1 score on scale
Standard Deviation 19.55
|
79.2 score on scale
Standard Deviation 14.41
|
78.0 score on scale
Standard Deviation 21.24
|
84.6 score on scale
Standard Deviation 15.42
|
74.5 score on scale
Standard Deviation 22.80
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
S: Social Functioning
|
80.0 score on scale
Standard Deviation 12.25
|
67.5 score on scale
Standard Deviation 22.83
|
50.8 score on scale
Standard Deviation 41.52
|
67.1 score on scale
Standard Deviation 22.87
|
75.7 score on scale
Standard Deviation 20.09
|
77.7 score on scale
Standard Deviation 11.66
|
80.8 score on scale
Standard Deviation 13.11
|
83.3 score on scale
Standard Deviation 15.07
|
76.3 score on scale
Standard Deviation 13.88
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
S: School/Work Functioning Report
|
82.0 score on scale
Standard Deviation 11.51
|
54.4 score on scale
Standard Deviation 14.25
|
40.8 score on scale
Standard Deviation 33.23
|
66.1 score on scale
Standard Deviation 17.66
|
71.4 score on scale
Standard Deviation 14.64
|
77.3 score on scale
Standard Deviation 13.33
|
77.8 score on scale
Standard Deviation 15.09
|
81.8 score on scale
Standard Deviation 14.89
|
77.1 score on scale
Standard Deviation 15.22
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
P: Physical Functioning Report
|
20.8 score on scale
Standard Deviation 5.82
|
25.0 score on scale
Standard Deviation 27.55
|
19.1 score on scale
Standard Deviation 24.54
|
24.9 score on scale
Standard Deviation 22.77
|
32.6 score on scale
Standard Deviation 30.07
|
28.6 score on scale
Standard Deviation 14.31
|
46.1 score on scale
Standard Deviation 21.47
|
35.2 score on scale
Standard Deviation 18.19
|
33.5 score on scale
Standard Deviation 18.41
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
P: Emotional Functioning Report
|
74.2 score on scale
Standard Deviation 11.14
|
68.1 score on scale
Standard Deviation 13.08
|
69.5 score on scale
Standard Deviation 17.23
|
58.7 score on scale
Standard Deviation 14.90
|
65.0 score on scale
Standard Deviation 26.46
|
72.7 score on scale
Standard Deviation 19.75
|
71.8 score on scale
Standard Deviation 19.84
|
78.0 score on scale
Standard Deviation 18.74
|
78.2 score on scale
Standard Deviation 19.60
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
P: Social Functioning Report
|
60.8 score on scale
Standard Deviation 13.20
|
47.5 score on scale
Standard Deviation 12.82
|
54.0 score on scale
Standard Deviation 23.66
|
51.3 score on scale
Standard Deviation 20.06
|
64.3 score on scale
Standard Deviation 22.63
|
71.9 score on scale
Standard Deviation 24.46
|
72.1 score on scale
Standard Deviation 16.96
|
70.0 score on scale
Standard Deviation 20.65
|
71.0 score on scale
Standard Deviation 17.50
|
|
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
P: School/Work Functioning Report
|
79.2 score on scale
Standard Deviation 9.70
|
48.8 score on scale
Standard Deviation 12.17
|
48.5 score on scale
Standard Deviation 31.23
|
51.4 score on scale
Standard Deviation 21.36
|
63.6 score on scale
Standard Deviation 18.64
|
76.5 score on scale
Standard Deviation 13.45
|
78.5 score on scale
Standard Deviation 18.44
|
78.8 score on scale
Standard Deviation 20.19
|
78.0 score on scale
Standard Deviation 14.75
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
The ACEND is a questionnaire that includes a total of seven domains assessing physical impact (including feeding/grooming/dressing, sitting/play, transfers, and mobility) and general caregiver impact (including time, emotion, and finance) and each domain comprises several items. The total score (TS) for each domain will be calculated on a scale of 0 to 100. Higher scores indicate a greater impact on the caregiver.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=6 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=10 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=11 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=38 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=9 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=18 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=47 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Feeding/Grooming/Dressing TS: Change MMDR Day1800
|
2.8 score on scale
Standard Deviation 7.72
|
14.2 score on scale
Standard Deviation 21.56
|
0.6 score on scale
Standard Deviation 2.01
|
18.5 score on scale
Standard Deviation 22.07
|
9.2 score on scale
Standard Deviation 15.91
|
2.1 score on scale
Standard Deviation 14.82
|
0.6 score on scale
Standard Deviation 2.43
|
4.6 score on scale
Standard Deviation 18.90
|
5.9 score on scale
Standard Deviation 12.07
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Sitting/Play TS: Change at MMDR Day 1800
|
-2.0 score on scale
Standard Deviation 4.90
|
0.8 score on scale
Standard Deviation 10.29
|
-0.4 score on scale
Standard Deviation 14.91
|
5.5 score on scale
Standard Deviation 28.01
|
1.5 score on scale
Standard Deviation 22.21
|
2.8 score on scale
Standard Deviation 12.04
|
0.0 score on scale
Standard Deviation 0.00
|
-1.8 score on scale
Standard Deviation 16.48
|
1.7 score on scale
Standard Deviation 16.08
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Transfers TS: Change at MMDR Day 1800
|
-4.0 score on scale
Standard Deviation 11.03
|
0.4 score on scale
Standard Deviation 7.24
|
0.7 score on scale
Standard Deviation 1.62
|
0.0 score on scale
Standard Deviation 12.32
|
-5.5 score on scale
Standard Deviation 6.68
|
-5.8 score on scale
Standard Deviation 15.14
|
1.4 score on scale
Standard Deviation 9.48
|
-3.6 score on scale
Standard Deviation 16.17
|
1.2 score on scale
Standard Deviation 18.16
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Mobility TS: Change at MMDR Day 1800
|
6.7 score on scale
Standard Deviation 20.66
|
-2.3 score on scale
Standard Deviation 14.93
|
0.5 score on scale
Standard Deviation 1.72
|
7.5 score on scale
Standard Deviation 22.52
|
-12.1 score on scale
Standard Deviation 18.69
|
-13.0 score on scale
Standard Deviation 13.83
|
-2.2 score on scale
Standard Deviation 7.86
|
1.9 score on scale
Standard Deviation 18.47
|
-5.8 score on scale
Standard Deviation 17.50
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Time TS: Change at MMDR Day 1800
|
-6.3 score on scale
Standard Deviation 14.25
|
4.4 score on scale
Standard Deviation 19.78
|
6.8 score on scale
Standard Deviation 24.76
|
-0.7 score on scale
Standard Deviation 22.60
|
-6.3 score on scale
Standard Deviation 21.65
|
-2.4 score on scale
Standard Deviation 18.14
|
2.6 score on scale
Standard Deviation 18.36
|
1.4 score on scale
Standard Deviation 17.22
|
0.5 score on scale
Standard Deviation 16.78
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Emotion TS: Change at MMDR Day 1800
|
-18.1 score on scale
Standard Deviation 12.01
|
5.0 score on scale
Standard Deviation 14.80
|
6.3 score on scale
Standard Deviation 15.82
|
-2.1 score on scale
Standard Deviation 20.98
|
2.1 score on scale
Standard Deviation 14.22
|
-2.4 score on scale
Standard Deviation 21.00
|
1.0 score on scale
Standard Deviation 13.25
|
4.7 score on scale
Standard Deviation 12.73
|
-2.5 score on scale
Standard Deviation 12.70
|
|
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
Finance TS: Change at MMDR Day 1800
|
-3.3 score on scale
Standard Deviation 8.16
|
-1.0 score on scale
Standard Deviation 17.29
|
7.3 score on scale
Standard Deviation 20.66
|
-4.1 score on scale
Standard Deviation 22.17
|
4.4 score on scale
Standard Deviation 18.98
|
-0.8 score on scale
Standard Deviation 20.70
|
4.1 score on scale
Standard Deviation 14.92
|
7.2 score on scale
Standard Deviation 17.92
|
2.1 score on scale
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=8 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Disease-related Hospitalizations and AEs
Disease-related AEs
|
8 Participants
|
11 Participants
|
21 Participants
|
60 Participants
|
7 Participants
|
16 Participants
|
12 Participants
|
36 Participants
|
68 Participants
|
|
Number of Participants With Disease-related Hospitalizations and AEs
Disease-related hospitalization
|
3 Participants
|
6 Participants
|
9 Participants
|
27 Participants
|
5 Participants
|
9 Participants
|
0 Participants
|
13 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: MMDR Period: up to Day 1800Population: All dosed population included all participants who received a dose of nusinersen or were in the sham treatment group. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
Survival rate was defined as the percentage of participants alive during the study and was estimated from the Kaplan Meier (KM) curve for time to death.
Outcome measures
| Measure |
Later SMA Onset 232SM202
n=25 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3A
n=13 Participants
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 Participants
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 Participants
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=42 Participants
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=83 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=8 Participants
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=20 Participants
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=12 Participants
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Survival Rate
|
100 percentage of participants
|
100 percentage of participants
|
79.16 percentage of participants
|
87.69 percentage of participants
|
97.61 percentage of participants
|
98.79 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
91.66 percentage of participants
|
Adverse Events
Infantile SMA Onset CS3A
Serious events: 11 serious events
Other events: 13 other events
Deaths: 0 deaths
Infantile SMA Onset CS3B Previous Control
Serious events: 23 serious events
Other events: 23 other events
Deaths: 5 deaths
Infantile SMA Onset CS3B Previous ISIS 396443
Serious events: 59 serious events
Other events: 65 other events
Deaths: 8 deaths
Infantile SMA Onset 232SM202
Serious events: 9 serious events
Other events: 12 other events
Deaths: 1 deaths
Later SMA Onset 232SM202
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Later SMA Onset CS12 Type 2
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Later SMA Onset CS12 Type 3
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Later SMA Onset CS4 Previous Control
Serious events: 26 serious events
Other events: 40 other events
Deaths: 1 deaths
Later SMA Onset CS4 Previous ISIS 396443
Serious events: 47 serious events
Other events: 79 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Infantile SMA Onset CS3A
n=13 participants at risk
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, intrathecal (IT) injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 participants at risk
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 participants at risk
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 participants at risk
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset 232SM202
n=8 participants at risk
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 participants at risk
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 participants at risk
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 participants at risk
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 participants at risk
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Neuromuscular scoliosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Retrognathia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
30.0%
6/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
26.2%
11/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
26.5%
22/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain stem glioma
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Altered state of consciousness
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Metapneumovirus infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Wolff-parkinson-white syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Laryngeal cleft
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Spinal muscular atrophy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Talipes
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Complication associated with device
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Complication of device insertion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Death
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Discomfort
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Generalised oedema
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Impaired healing
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Medical device discomfort
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Sudden death
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Immune system disorders
Cytokine storm
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Coronavirus pneumonia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Covid-19
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Device related infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Human bocavirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pharyngotonsillitis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.3%
8/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.5%
27/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.7%
5/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.0%
8/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia moraxella
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia serratia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pseudomonas bronchitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pyuria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
18.5%
12/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.3%
8/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Varicella
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Viral infection
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Musculoskeletal procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Neurological procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Respiratory tract procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Blood culture positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Enterovirus test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Rubulavirus test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Product Issues
Device failure
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Product Issues
Device malfunction
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Product Issues
Device mechanical issue
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
37.5%
9/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
23.1%
15/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Surgical and medical procedures
Positive airway pressure therapy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
Other adverse events
| Measure |
Infantile SMA Onset CS3A
n=13 participants at risk
Participants who received nusinersen in study ISIS 396443-CS3A, in an open-label period, received maintenance doses of nusinersen, intrathecal (IT) injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous Control
n=24 participants at risk
Participants who received sham procedures in study ISIS 396443-CS3B, in a double-blind period, received 4 loading doses of nusinersen IT injection on Days 1, 15, 29, and 64 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset CS3B Previous ISIS 396443
n=65 participants at risk
Participants who received nusinersen in study ISIS 396443-CS3B, in the double-blind period, received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen IT injection on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Infantile SMA Onset 232SM202
n=12 participants at risk
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset 232SM202
n=8 participants at risk
Participants who received nusinersen in study 232SM202 (i.e., Part 2) in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 2
n=20 participants at risk
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS12 Type 3
n=25 participants at risk
Participants who received nusinersen in study ISIS 396443-CS12 in an open-label period, received maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous Control
n=42 participants at risk
Participants who received sham procedures in the study ISIS 396443-CS4 in a double-blind period received 3 loading doses of nusinersen administered by IT injection on Days 1, 29, and 85 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
Later SMA Onset CS4 Previous ISIS 396443
n=83 participants at risk
Participants who received nusinersen in the study ISIS 396443-CS4 in a double-blind period received 2 loading doses of nusinersen administered by IT injection on Days 1 and 85 and 1 sham procedure on Day 29 followed by maintenance doses of nusinersen IT injection, on days 1, 120, 240, 360, 480, 600, 720, 840, 960, 1080, 1200, 1320, 1440, 1560, and 1680 in MMDR period of this study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Extraskeletal ossification
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.0%
6/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
21.4%
9/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
22.9%
19/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Metapneumovirus infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Moraxella infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Mycoplasma infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Nasopharyngitis
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
40.0%
26/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.3%
4/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
4/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
32.0%
8/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
31.0%
13/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
32.5%
27/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Oral candidiasis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis externa
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis media
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
21.5%
14/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
4/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Otitis media acute
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Parainfluenzae virus infection
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
27.7%
18/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.3%
4/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
14.3%
6/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.3%
11/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.9%
11/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.3%
8/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory tract infection
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.8%
22/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Respiratory tract infection viral
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
18.5%
12/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Serratia infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Stoma site infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Suspected covid-19
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Tonsillitis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Upper respiratory tract infection
|
84.6%
11/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
58.3%
14/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
52.3%
34/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
75.0%
6/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
40.0%
8/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
5/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
50.0%
21/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
39.8%
33/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Urinary tract infection
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.4%
7/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Viral infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.0%
4/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
10/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Accident
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
5/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Palate injury
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
65.0%
13/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
60.0%
15/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
7/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.3%
21/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
38.5%
5/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
23.1%
15/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
30.0%
6/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
44.0%
11/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
45.2%
19/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
34.9%
29/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Respiratory tract procedural complication
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Stoma site discharge
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Stoma site hypergranulation
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Blood iron decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Bone density decreased
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Breath sounds abnormal
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Cardiac murmur
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Clostridium test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Crystal urine present
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Electrocardiogram qt prolonged
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Heart rate increased
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Mean platelet volume decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Occult blood positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Oxygen consumption decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Oxygen saturation decreased
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
29.2%
7/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
27.7%
18/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Platelet count increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Prothrombin time prolonged
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Qrs axis abnormal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Sars-cov-2 test positive
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Vitamin d decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Von willebrand's factor activity decreased
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
Weight increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
White blood cell count increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Malnutrition
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
44.0%
11/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
26.2%
11/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
18.1%
15/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Deformity thorax
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.6%
16/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
40.0%
8/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
26.2%
11/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.3%
21/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Joint laxity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Limb asymmetry
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
38.5%
5/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
27.7%
18/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
30.0%
6/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
40.5%
17/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
44.6%
37/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Neuromuscular scoliosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.0%
6/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
46.2%
6/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.7%
10/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
58.5%
38/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
62.5%
5/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
30.0%
6/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
52.4%
22/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
39.8%
33/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Musculoskeletal and connective tissue disorders
Tendinous contracture
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Areflexia
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Cognitive disorder
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Disturbance in attention
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.3%
8/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
37.5%
3/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
5/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
68.0%
17/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
47.6%
20/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
28.9%
24/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Hyporeflexia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Motor developmental delay
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Learning disability
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Product Issues
Device dislocation
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Product Issues
Device malfunction
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Anxiety disorder
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Encopresis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Kidney enlargement
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Reproductive system and breast disorders
Testicular atrophy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
38.5%
5/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial wall thickening
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.6%
16/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.7%
5/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
62.5%
5/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
30.0%
6/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
35.7%
15/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
34.9%
29/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.9%
11/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.3%
8/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of upper respiratory secretion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
9/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Noninfective bronchitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
4/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.0%
8/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
14.5%
12/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.8%
7/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
14.3%
6/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.6%
8/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.2%
6/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Bradycardia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Pericardial effusion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Right atrial enlargement
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Cardiac disorders
Tachycardia
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Congenital, familial and genetic disorders
High arched palate
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Ear and labyrinth disorders
Ear pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Ear and labyrinth disorders
Hyperacusis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Ear and labyrinth disorders
Myringosclerosis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Amblyopia
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Astigmatism
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Chalazion
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Eyelid cyst
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Hypermetropia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Myopia
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Eye disorders
Strabismus
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.4%
7/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
29.2%
7/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.8%
22/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
37.5%
3/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
21.4%
9/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.3%
11/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
33.3%
8/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.6%
16/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
14.3%
6/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.3%
11/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
2/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.8%
5/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Ileus paralytic
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Lip dry
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.2%
6/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.0%
8/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
18.1%
15/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Saliva discolouration
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
6/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Scalloped tongue
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
7/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
37.5%
9/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
35.4%
23/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
50.0%
4/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
35.0%
7/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.0%
4/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
42.9%
18/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
42.2%
35/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Developmental delay
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Fatigue
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.7%
5/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
3/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Infusion site bruising
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Medical device site haemorrhage
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Pain
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.6%
3/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Pneumatosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
General disorders
Pyrexia
|
100.0%
13/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
62.5%
15/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
76.9%
50/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.7%
5/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
62.5%
5/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
50.0%
10/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
50.0%
21/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
47.0%
39/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.0%
2/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
7.1%
3/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
4/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bronchiolitis
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.4%
10/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
7/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.0%
5/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Clostridium difficile infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Conjunctivitis
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.3%
8/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.8%
4/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Coronavirus infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Covid-19
|
30.8%
4/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
24.6%
16/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
41.7%
5/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
25.0%
2/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
4/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
5/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.0%
8/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.3%
16/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Croup infectious
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Ear infection
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
32.3%
21/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.0%
1/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.9%
14/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Ear infection fungal
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Eye infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.1%
2/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
10.0%
2/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.8%
9/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
16.7%
2/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
15.0%
3/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
9.5%
4/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
13.3%
11/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
4.2%
1/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
35.0%
7/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
5/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
11.9%
5/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.5%
1/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
1/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
2/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Impetigo
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
5.0%
1/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
2.4%
1/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
1.2%
1/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Influenza
|
15.4%
2/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
13/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
20.0%
4/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.0%
3/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
14.3%
6/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
19.3%
16/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
8.3%
2/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.7%
1/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
3/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
6.2%
4/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
3.6%
3/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/13 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/24 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/65 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/12 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
12.5%
1/8 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/20 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/25 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/42 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
0.00%
0/83 • From Day 1 up to the end of the study (up to 2848 days)
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER