A Study for Participants With Spinal Muscular Atrophy (SM... | NCT02594124 | Trialant
NCT02594124
Sponsor
Biogen
Status
Completed
Last Update Posted
Oct 22, 2024Actual
Enrollment
292Actual
Phase
Phase 3
Conditions
Spinal Muscular Atrophy
Interventions
nusinersen
Countries
United States
Australia
Belgium
Canada
France
Germany
Hong Kong
Italy
Japan
South Korea
Spain
Sweden
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02594124
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ISIS 396443-CS11
Secondary IDs
ID
Type
Description
Link
2015-001870-16
EudraCT Number
Brief Title
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
Official Title
An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443
Acronym
SHINE
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT02865109No longer available
Start Date
Nov 4, 2015Actual
Primary Completion Date
Aug 21, 2023Actual
Completion Date
Aug 21, 2023Actual
First Submitted Date
Oct 30, 2015
First Submission Date that Met QC Criteria
Oct 30, 2015
First Posted Date
Nov 2, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 14, 2024
Results First Submitted that Met QC Criteria
Sep 27, 2024
Results First Posted Date
Oct 22, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 27, 2024
Last Update Posted Date
Oct 22, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.
Detailed Description
This study was initiated and the protocol was registered by Ionis Pharmaceuticals, Inc.
In August 2016, Biogen assumed responsibility for this study.
Conditions Module
Conditions
Spinal Muscular Atrophy
Keywords
SMA
SMN
SMNRx
ISIS-SMNRx
ISIS 396443
SHINE
IONIS-SMNRx
IONIS-SMN Rx
Spinraza
nusinersen
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
292Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Participants transitioned from ISIS 396443-CS3B (NCT02193074)
Drug: nusinersen
Group 2
Experimental
Participants transitioned from ISIS 396443-CS4 (NCT02292537)
Drug: nusinersen
Group 3
Experimental
Participants transitioned from ISIS 396443-CS12 (NCT02052791)
Drug: nusinersen
Group 4
Experimental
Participants transitioned from ISIS 396443-CS3A (NCT01839656)
Drug: nusinersen
Group 5
Experimental
Participants transitioned from 232SM202 (NCT02462759)
Drug: nusinersen
Interventions
Name
Type
Description
Arm Group Labels
Other Names
nusinersen
Drug
Administered by intrathecal (IT) injection
Group 1
Group 2
Group 3
Group 4
Group 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants With Vital Sign Abnormalities Reported as AEs
The vital sign assessments included blood pressure, temperature, pulse rate, and respiratory rate. Participants with abnormalities in these assessments recorded as AEs were reported.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants With Weight Abnormalities Reported as AEs
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.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants With Neurological Abnormalities Reported as AEs
Participants with abnormalities in neurological examinations recorded as AEs were reported.
From Day 1 up to the end of the study (up to 2848 days)
Secondary Outcomes
Measure
Description
Time Frame
Mean Number of New Motor Milestones Achieved as Assessed by World Health Organization (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, 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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Signed informed consent of parent or guardian and signed informed assent of participant, if indicated per participant's age and institutional guidelines.
Completion of the index study in accordance with the study protocol or as a result of Sponsor decision (e.g., early termination of the index study) within the preceding 16 weeks
Key Exclusion Criteria:
Have any condition or worsening condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
Clinically significant abnormalities in hematology or clinical chemistry parameters or electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study
Participant's parent or legal guardian is not willing or able to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study
Treatment with another investigational agent, biological agent, or device within one month of Screening, or 5 half-lives of study agent, whichever is longer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Kokaliaris C, Evans R, Hawkins N, Mahajan A, Scott DA, Sutherland CS, Nam J, Sajeev G. Long-Term Comparative Efficacy and Safety of Risdiplam and Nusinersen in Children with Type 1 Spinal Muscular Atrophy. Adv Ther. 2024 Jun;41(6):2414-2434. doi: 10.1007/s12325-024-02845-6. Epub 2024 May 5.
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.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 20, 2021
Aug 14, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Taiwan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
During the blinded loading period, the following participants will be masked:
Key site personnel (Investigator, Study Coordinator, and Outcomes Assessors)
Participant
The sponsor
After the loading period has been completed, subsequent doses will be unblinded.
Who Masked
Not provided
ISIS 396443
Spinraza
BIIB058
IONIS SMN Rx
ISIS SMNRx
Number of Participants With Laboratory Abnormalities Reported as AEs
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants With Coagulation Parameters Reported as AEs
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.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants With Clinically Significant Shifts in12 Lead Electrocardiogram (ECG) Results
Clinical significance of abnormalities in 12 lead ECG was determined based on the investigator's discretion.
From Day 1 up to the end of the study (up to 2848 days)
Number of Participants Taking Any Concomitant Medication
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.
From Day 1 up to the end of the study (up to 2848 days)
MMDR Period: At Day 1800
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
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.
At Day 309
Number of Participants Who Died or Met Permanent Ventilation
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.
MMDR Period: Up to Day 1800
Number of Participants Not Requiring Permanent Ventilation
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.
MMDR Period: Up to Day 1800
Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Motor Function Scale
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.
Baseline, Day 2198
Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score
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.
MMDR Period: Baseline, MMDR Day 1800
Change From Baseline in Revised Upper Limb Module (RULM) Total Score
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.
MMDR Period: Baseline, MMDR Day 1800
Change From Baseline in Total Distance Walked Over Time as Assessed by 6-Minute Walk Test (6MWT)
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.
Baseline, Day 2670
Number of Participants Who Experienced Contracture Assesment
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.
MMDR Period: At MMDR Day 1800
Change From Baseline in Compound Muscular Action Potential (CMAP)
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.
MMDR Period: Baseline, MMDR Day 1800
Change From Baseline in Body Length
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.
MMDR Period: up to Day 1800
Change From Baseline in Weight
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.
MMDR Period: up to Day 1800
Change From Baseline in Weight for Age Percentile
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.
MMDR Period: up to Day 1800
Percentage of CMAP Responders
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).
MMDR Period: At Day 1800
Number of Participants Who Achieved Motor Milestones
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).
MMDR Period: up to Day 1800
Number of Participants Who Achieved Standing Alone and Walking With Assistance
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.
MMDR Period: up to Day 1800
Total Number of Hospitalizations Due to Serious Respiratory Events
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.
Up to day 2520
Total Number of Hospitalizations Due to Serious Adverse Events
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.
Up to day 2520
Percent of Time in Hospitalization
Upto day 2160
Change From Baseline in Cobb-Angle on X-Ray of the Thoracolumbar Spine by Visit
Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define scoliosis.
MMDR Period: Baseline, MMDR Day 1800
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
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.
MMDR Period: At Day 1800
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
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.
MMDR Period: up to Day 1800
Number of Participants With Disease-related Hospitalizations and AEs
MMDR Period: up to Day 1800
Survival Rate
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.
MMDR Period: up to Day 1800
Palo Alto
California
94305
United States
Children's Hospital Colorado
Aurora
Colorado
80045
United States
Connecticut Children's Medical Center
Hartford
Connecticut
06106
United States
Nemours Children's Clinic
Orlando
Florida
32827
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
New York
Illinois
60611
United States
The Johns Hopkins Hospital
Baltimore
Maryland
21287
United States
Boston Children's Hospital
Boston
Massachusetts
02115
United States
Gillette Children's Specialty Healthcare
Saint Paul
Minnesota
55101
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Columbia University Medical Center
New York
New York
10032
United States
Duke University School of Medicine
Durham
North Carolina
27710
United States
Duke University School of Medicine
Miyagi
North Carolina
27710
United States
Oregon Health Sciences University
Durham
Oregon
97239
United States
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
19104
United States
Children's Medical Center
Dallas
Texas
75235
United States
University of Utah
Obu, Aichi
Utah
84112
United States
Seattle Children's Hospital
Seattle
Washington
98105
United States
Sydney Children's Hospital Clinical Research Centre
Sydney
New South Wales
2031
Australia
Royal Children's Hospital
Parkville
Victoria
3052
Australia
Universitair Kinderziekenhuis Koningin Fabiola
Brussels
1020
Belgium
BC Children's Hospital / UBC
Vancouver
British Columbia
V6H 3V4
Canada
Children's Health Research Institute
Brussel
Ontario
N6A 5W9
Canada
McGill University Health Centre
Montreal
Quebec
H4A 3J1
Canada
Armand Trousseau Hospital, I-Motion
Paris
Paris 9
75012
France
LMU-Campus Innenstadt
Munich
Bavaria
80337
Germany
Universitatsklinikum Essen
Essen
45147
Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau
79106
Germany
The University of Hong Kong
Hong Kong
Hong Kong SAR
999077
Hong Kong
Pediatric Neurology Unit, Catholic University
Essen
00168
Italy
Istituto Giannina Gaslini, Centro Traslazionale di Miologia
Genova
16147
Italy
Department of Neuroscience, Università di Messina, AOU Polic
Messina
98125
Italy
Aichi Children's Health and Medical Center
Ōbu
Aichi-ken
474-0038
Japan
Hyogo College of Medicine
Nishinomiya
Hyōgo
663-8501
Japan
Tokyo Women's Medical University
Shinjuku-ku
Tokyo
162-8666
Japan
Kumamoto University Hospital
Kumamoto
860-8556
Japan
Miyagi Prefectural Children Hospital
Miyagi
989-3126
Japan
University of Miyazaki Hospital
Miyazaki
889-1692
Japan
Seoul National University Hospital
Seoul
Korea
3080
South Korea
Hospital Sant Joan de Deu
Barcelona
08950
Spain
Hospital Universitario Vall de Hebron
Hebron
08035
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
The Queen Silvia Children's Hospital
Gothenburg
SE 416 86
Sweden
Uníversity of Hacettepe
Ankara
6100
Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul
34662
Turkey (Türkiye)
MRC Centre for Neuromuscular Diseases at Newcastle
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
FG008
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.
FG00013 subjects
FG00124 subjects
FG00265 subjects
FG00312 subjects
FG00420 subjects
FG00525 subjects
FG00642 subjects
FG00783 subjects
FG0088 subjects
COMPLETED
FG00010 subjects
FG00110 subjects
FG00242 subjects
FG0037 subjects
FG00412 subjects
FG00520 subjects
FG00619 subjects
FG00744 subjects
FG0085 subjects
NOT COMPLETED
FG0003 subjects
FG00114 subjects
FG00223 subjects
FG0035 subjects
FG0048 subjects
FG0055 subjects
FG00623 subjects
FG00739 subjects
FG0083 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0015 subjects
FG0028 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0025 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Commercial drug
FG0000 subjects
FG0011 subjects
FG0026 subjects
FG0033 subjects
FG004
Reason Not Specified
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG004
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Infantile SMA Onset CS3A
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00124
BG00265
BG00312
BG00420
BG00525
BG00642
BG00783
BG0088
BG009292
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Infants and toddlers (28 days-23 months)
BG0000
BG00124
BG00265
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
Later SMA Onset CS12 Type 3
Units
Counts
Participants
OG00013
OG00124
OG00265
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00013
OG00124
OG00265
OG003
Primary
Number of Participants With Vital Sign Abnormalities Reported as AEs
The vital sign assessments included blood pressure, temperature, pulse rate, and respiratory rate. Participants with abnormalities in these assessments recorded as AEs were reported.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Primary
Number of Participants With Weight Abnormalities Reported as AEs
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. '
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Primary
Number of Participants With Neurological Abnormalities Reported as AEs
Participants with abnormalities in neurological examinations recorded as AEs were reported.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
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.
Primary
Number of Participants With Laboratory Abnormalities Reported as AEs
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Primary
Number of Participants With Coagulation Parameters Reported as AEs
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Primary
Number of Participants With Clinically Significant Shifts in12 Lead Electrocardiogram (ECG) Results
Clinical significance of abnormalities in 12 lead ECG was determined based on the investigator's discretion.
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.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Primary
Number of Participants Taking Any Concomitant Medication
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
From Day 1 up to the end of the study (up to 2848 days)
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Secondary
Mean Number of New Motor Milestones Achieved as Assessed by World Health Organization (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, 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.
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.
Posted
Mean
Standard Deviation
motor milestone
MMDR Period: At Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE)
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.
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).
Posted
Number
percentage of participants
At Day 309
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
Secondary
Number of Participants Who Died or Met Permanent Ventilation
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
MMDR Period: Up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Secondary
Number of Participants Not Requiring Permanent Ventilation
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.
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
MMDR Period: Up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Secondary
Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Motor Function Scale
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.
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.
Posted
Mean
Standard Deviation
score on scale
Baseline, Day 2198
ID
Title
Description
OG000
Infantile SMA Onset CS3A
Participants who entered the study after receiving nusinersen in the open-label study ISIS 396443-CS3A received maintenance doses of nusinersen approximately every 4 months according to the MMDR dosing schedule.
OG001
Infantile SMA Onset CS3B Previous Control
Secondary
Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score
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.
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.
Posted
Mean
Standard Deviation
score on scale
MMDR Period: Baseline, MMDR Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Change From Baseline in Revised Upper Limb Module (RULM) Total Score
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.
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.
Posted
Mean
Standard Deviation
score on scale
MMDR Period: Baseline, MMDR Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
Infantile SMA Onset CS3B Previous Control
Secondary
Change From Baseline in Total Distance Walked Over Time as Assessed by 6-Minute Walk Test (6MWT)
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.
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.
Posted
Mean
Standard Deviation
meters
Baseline, Day 2670
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Number of Participants Who Experienced Contracture Assesment
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.
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.
Posted
Count of Participants
Participants
MMDR Period: At MMDR Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Change From Baseline in Compound Muscular Action Potential (CMAP)
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.
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.
Posted
Mean
Standard Deviation
millivolt (mV)
MMDR Period: Baseline, MMDR Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Change From Baseline in Body Length
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.
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.
Posted
Mean
Standard Deviation
centimeters (cm)
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Change From Baseline in Weight
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.
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.
Posted
Mean
Standard Deviation
kilograms (kg)
MMDR Period: up to Day 1800
ID
Title
Description
OG000
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 MMDR period of this study.
OG001
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.
Secondary
Change From Baseline in Weight for Age Percentile
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.
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.
Posted
Mean
Standard Deviation
percentile
MMDR Period: up to Day 1800
ID
Title
Description
OG000
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 MMDR period of this study.
OG001
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.
Secondary
Percentage of CMAP Responders
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).
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.
Posted
Number
percentage of responders
MMDR Period: At Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Number of Participants Who Achieved Motor Milestones
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).
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.
Posted
Count of Participants
Participants
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Number of Participants Who Achieved Standing Alone and Walking With Assistance
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.
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.
Posted
Count of Participants
Participants
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Total Number of Hospitalizations Due to Serious Respiratory Events
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.
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.
Posted
Number
number of hospitalizations
Up to day 2520
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Total Number of Hospitalizations Due to Serious Adverse Events
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.
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.
Posted
Number
number of hospitalizations
Up to day 2520
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Percent of Time in Hospitalization
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.
Posted
Median
Full Range
percentage of days
Upto day 2160
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Secondary
Change From Baseline in Cobb-Angle on X-Ray of the Thoracolumbar Spine by Visit
Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define scoliosis.
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.
Posted
Mean
Standard Deviation
degree
MMDR Period: Baseline, MMDR Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Pediatric Quality of Life Inventory (PedsQL) Questionnaires Total Score by Domain
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.
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.
Posted
Mean
Standard Deviation
score on scale
MMDR Period: At Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
Secondary
Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Questionnaire Total Score
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.
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.
Posted
Mean
Standard Deviation
score on scale
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
Secondary
Number of Participants With Disease-related Hospitalizations and AEs
The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
Posted
Count of Participants
Participants
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
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.
Secondary
Survival Rate
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.
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.
Posted
Number
percentage of participants
MMDR Period: up to Day 1800
ID
Title
Description
OG000
Infantile SMA Onset CS3A
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.
OG001
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.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Time Frame
From Day 1 up to the end of the study (up to 2848 days)
Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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 MMDR period of this study.
0
13
11
13
13
13
EG001
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.
5
24
23
24
23
24
EG002
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.
8
65
59
65
65
65
EG003
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.
1
12
9
12
12
12
EG004
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.
0
8
5
8
8
8
EG005
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.
0
20
12
20
20
20
EG006
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.
0
25
6
25
25
25
EG007
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.
1
42
26
42
40
42
EG008
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.
1
83
47
83
79
83
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG0030 affected12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Wolff-parkinson-white syndrome
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Laryngeal cleft
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Spinal muscular atrophy
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Talipes
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Acetonaemic vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Cyclic vomiting syndrome
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0025 affected65 at risk
EG003
Complication associated with device
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Complication of device insertion
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Generalised oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Impaired healing
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Medical device discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Sudden death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Cytokine storm
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Bronchitis pneumococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Coronavirus pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Enterovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0026 affected65 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Gastroenteritis adenovirus
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Haemophilus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Human bocavirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Incision site abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Intestinal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0027 affected65 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Medical device site abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Osteomyelitis chronic
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0026 affected65 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pneumococcal bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0018 affected24 at risk
EG00227 affected65 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0026 affected65 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Pneumonia moraxella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Pneumonia serratia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pseudomonas bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pyuria
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG00212 affected65 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0028 affected65 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0015 affected24 at risk
EG0025 affected65 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0025 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Varicella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Viral pericarditis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Foreign body aspiration
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Foreign body in respiratory tract
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastrointestinal procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastrostomy tube site complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Musculoskeletal procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Neurological procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Respiratory tract procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Unintentional medical device removal
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Blood culture positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Coronavirus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Enterovirus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Human rhinovirus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0023 affected65 at risk
EG003
Respiratory rate increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Respiratory syncytial virus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Rubulavirus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Feeding intolerance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hip deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Kyphoscoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Neuromuscular scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Retrognathia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG00210 affected65 at risk
EG003
Brain stem glioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hair follicle tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Brain hypoxia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Device failure
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Device malfunction
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Device mechanical issue
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Testicular torsion
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0019 affected24 at risk
EG00215 affected65 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0025 affected65 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Bronchial secretion retention
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0015 affected24 at risk
EG0029 affected65 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0029 affected65 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Positive airway pressure therapy
Surgical and medical procedures
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0026 affected65 at risk
EG0031 affected12 at risk
EG0041 affected8 at risk
EG0052 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0081 affected83 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0026 affected65 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Right atrial enlargement
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Right ventricular hypertrophy
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0014 affected24 at risk
EG0025 affected65 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
High arched palate
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Myringosclerosis
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Precocious puberty
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Amblyopia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Astigmatism
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Chalazion
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Eyelid cyst
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hypermetropia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Myopia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Strabismus
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0017 affected24 at risk
EG00222 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0018 affected24 at risk
EG00216 affected65 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0025 affected65 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0015 affected24 at risk
EG0022 affected65 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0029 affected65 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0026 affected65 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Saliva discolouration
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0016 affected24 at risk
EG00210 affected65 at risk
EG003
Scalloped tongue
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0029 affected65 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 affected13 at risk
EG0019 affected24 at risk
EG00223 affected65 at risk
EG003
Developmental delay
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0025 affected65 at risk
EG003
Gait disturbance
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Infusion site bruising
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Medical device site haemorrhage
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG0023 affected65 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Pneumatosis
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00013 affected13 at risk
EG00115 affected24 at risk
EG00250 affected65 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0029 affected65 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Bacterial disease carrier
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0024 affected65 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG00210 affected65 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG0028 affected65 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0011 affected24 at risk
EG00216 affected65 at risk
EG003
Coxsackie viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Ear infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG00221 affected65 at risk
EG003
Ear infection fungal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Enterovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0024 affected65 at risk
EG003
Eye infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0029 affected65 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Impetigo
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG00213 affected65 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0013 affected24 at risk
EG0024 affected65 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Moraxella infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Mycoplasma infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0015 affected24 at risk
EG00226 affected65 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0013 affected24 at risk
EG0020 affected65 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0014 affected24 at risk
EG00214 affected65 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG0025 affected65 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0016 affected24 at risk
EG00218 affected65 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0027 affected65 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0016 affected24 at risk
EG00211 affected65 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0012 affected24 at risk
EG0028 affected65 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0012 affected24 at risk
EG00222 affected65 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0026 affected65 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0016 affected24 at risk
EG0025 affected65 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG00212 affected65 at risk
EG003
Serratia infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0026 affected65 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0027 affected65 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Stoma site cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Suspected covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0023 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00011 affected13 at risk
EG00114 affected24 at risk
EG00234 affected65 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0013 affected24 at risk
EG00210 affected65 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0025 affected65 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Anaesthetic complication neurological
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Endotracheal intubation complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Extraskeletal ossification
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0013 affected24 at risk
EG0026 affected65 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG0025 affected65 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Incision site swelling
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0027 affected65 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Palate injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0014 affected24 at risk
EG0024 affected65 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Post procedural constipation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0025 affected65 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0005 affected13 at risk
EG0015 affected24 at risk
EG00215 affected65 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Respiratory tract procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Stoma site discharge
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Stoma site erythema
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Stoma site hypergranulation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0014 affected24 at risk
EG0025 affected65 at risk
EG003
Suture rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Blood iron decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Bone density decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Cardiac murmur
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Clostridium test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Crystal urine present
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Heart rate increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Mean platelet volume decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Occult blood positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Oxygen consumption decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0017 affected24 at risk
EG00218 affected65 at risk
EG003
Platelet count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pseudomonas test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0026 affected65 at risk
EG003
Qrs axis abnormal
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Red blood cell count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Red blood cell sedimentation rate increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Sars-cov-2 test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Vitamin d decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Von willebrand's factor activity decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Weight increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
White blood cell count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0026 affected65 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Feeding intolerance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0013 affected24 at risk
EG00210 affected65 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0026 affected65 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0013 affected24 at risk
EG0024 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0027 affected65 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Deformity thorax
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hip deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0029 affected65 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0016 affected24 at risk
EG00216 affected65 at risk
EG003
Joint laxity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Kyphoscoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0025 affected65 at risk
EG003
Kyphosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG00210 affected65 at risk
EG003
Limb asymmetry
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected13 at risk
EG0016 affected24 at risk
EG00218 affected65 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Neuromuscular scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0029 affected65 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0027 affected65 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0014 affected24 at risk
EG0027 affected65 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0006 affected13 at risk
EG00110 affected24 at risk
EG00238 affected65 at risk
EG003
Spinal deformity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tendinous contracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Hair follicle tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Areflexia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Autonomic nervous system imbalance
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0013 affected24 at risk
EG0028 affected65 at risk
EG003
Horner's syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Migraine
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Motor developmental delay
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Device dislocation
Product Issues
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0025 affected65 at risk
EG003
Device malfunction
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Encopresis
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0024 affected65 at risk
EG003
Learning disability
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Kidney enlargement
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0027 affected65 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Testicular atrophy
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0025 affected65 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected13 at risk
EG0012 affected24 at risk
EG0029 affected65 at risk
EG003
Bronchial wall thickening
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0020 affected65 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected13 at risk
EG0014 affected24 at risk
EG00216 affected65 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Epiglottic oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG00211 affected65 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0024 affected65 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0014 affected24 at risk
EG0028 affected65 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0026 affected65 at risk
EG003
Increased viscosity of upper respiratory secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0026 affected65 at risk
EG003
Noninfective bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0022 affected65 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0015 affected24 at risk
EG0025 affected65 at risk
EG003
Restrictive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0021 affected65 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected13 at risk
EG0012 affected24 at risk
EG0027 affected65 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0024 affected65 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0021 affected65 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0021 affected65 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0023 affected65 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0023 affected65 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0022 affected65 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected24 at risk
EG0023 affected65 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0020 affected65 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0013 affected24 at risk
EG0022 affected65 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected13 at risk
EG0014 affected24 at risk
EG0027 affected65 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0020 affected65 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected24 at risk
EG0020 affected65 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected24 at risk
EG0022 affected65 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0021 affected65 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected24 at risk
EG0023 affected65 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
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.
OG006
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.
OG007
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.
OG008
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.
12
OG00420
OG00525
OG00642
OG00783
OG0088
12
OG00420
OG00525
OG00642
OG00780
OG0088
SAEs
Title
Measurements
OG00011
OG00123
OG00259
OG0039
OG00412
OG0056
OG00626
OG00747
OG0085
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Bradycardia
Title
Measurements
OG0001
OG0010
OG0026
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
Tachycardia
Title
Measurements
OG0002
OG0014
OG0025
OG003
Pyrexia
Title
Measurements
OG00013
OG00115
OG00250
OG003
Body Temperature Increased
Title
Measurements
OG0000
OG0011
OG0021
OG003
Heart Rate Increased
Title
Measurements
OG0003
OG0012
OG0024
OG003
Oxygen Saturation Decreased
Title
Measurements
OG0001
OG0019
OG00220
OG003
Respiratory Rate Increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Tachypnoea
Title
Measurements
OG0000
OG0010
OG0021
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Weight Decreased
Title
Measurements
OG0000
OG0010
OG0023
OG0031
OG0040
OG0051
OG0061
OG0073
OG0080
Weight Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Areflexia
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0041
OG0050
OG0061
OG0071
OG0080
Hyporeflexia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Nystagmus
Title
Measurements
OG0000
OG0010
OG0024
OG003
Motor Dysfunction
Title
Measurements
OG0000
OG0010
OG0021
OG003
Muscle Contractions Involuntary
Title
Measurements
OG0000
OG0010
OG0020
OG003
Myoclonus
Title
Measurements
OG0000
OG0010
OG0020
OG003
Paraesthesia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Tremor
Title
Measurements
OG0001
OG0010
OG0021
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0001
OG0010
OG0026
OG0031
OG0042
OG0050
OG0061
OG0071
OG0081
Leukocytosis
Title
Measurements
OG0001
OG0010
OG0023
OG003
Leukopenia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Neutrophilia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Pancytopenia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Thrombocytosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypertransaminasaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Pyuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urinary Tract Infection
Title
Measurements
OG0003
OG0013
OG00211
OG003
Alanine Aminotransferase Increased
Title
Measurements
OG0000
OG0011
OG0023
OG003
Aspartate Aminotransferase Increased
Title
Measurements
OG0000
OG0011
OG0022
OG003
Blood Albumin Decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Bicarbonate Decreased
Title
Measurements
OG0000
OG0010
OG0022
OG003
Blood Calcium Decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Blood Osmolarity Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Potassium Abnormal
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood Potassium Decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood Potassium Increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Crystal Urine Present
Title
Measurements
OG0000
OG0010
OG0020
OG003
Full Blood Count Decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Full Blood Count Increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Gamma-Glutamyltransferase Increased
Title
Measurements
OG0000
OG0012
OG0023
OG003
Haemoglobin Decreased
Title
Measurements
OG0000
OG0011
OG0022
OG003
Hepatic Enzyme Increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Liver Function Test Increased
Title
Measurements
OG0000
OG0011
OG0021
OG003
Mean Platelet Volume Decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil Count Decreased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophil Count Increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet Count Decreased
Title
Measurements
OG0000
OG0010
OG0022
OG003
Platelet Count Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Protein Urine Present
Title
Measurements
OG0000
OG0011
OG0021
OG003
Red Blood Cell Count Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Transaminases Increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urine Ketone Body Present
Title
Measurements
OG0000
OG0010
OG0020
OG003
White Blood Cell Count Increased
Title
Measurements
OG0000
OG0010
OG0024
OG003
White Blood Cells Urine
Title
Measurements
OG0000
OG0010
OG0021
OG003
White Blood Cells Urine Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercalcaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hyperglycaemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypernatraemia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypochloraemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypoglycaemia
Title
Measurements
OG0002
OG0010
OG0025
OG003
Hypokalaemia
Title
Measurements
OG0001
OG0013
OG00210
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Electrolyte Imbalance
Title
Measurements
OG0000
OG0010
OG0021
OG003
Bilirubinuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Haematuria
Title
Measurements
OG0001
OG0011
OG0020
OG003
Ketonuria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocyturia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Proteinuria
Title
Measurements
OG0000
OG0011
OG0027
OG003
Bandaemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
Later SMA Onset 232SM202
Participants entering the study after receiving nusinersen during the open-label phase of Study 232SM202 (i.e., Part 2) received maintenance doses of nusinersen approximately every 4 months according to the MMDR dosing schedule.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Activated Partial Thromboplastin Time Prolonged
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
International Normalised Ratio Abnormal
Title
Measurements
OG0000
OG0010
OG0021
OG003
International Normalised Ratio Decreased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Coagulopathy
Title
Measurements
OG0000
OG0010
OG0021
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0026
OG0031
OG0040
OG0050
OG0061
OG0071
OG0080
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Title
Measurements
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0009
OG00110
OG00243
OG0038
OG00412
OG00518
OG00619
OG00745
OG0086
Title
Denominators
Categories
Title
Measurements
OG0000.4± 0.73
OG0010.0± 0.00
OG0020.7± 1.15
OG0030.0± 0.53
OG004-0.6± 0.79
OG005-0.1± 0.73
OG006-0.1± 0.32
OG007-0.2± 0.60
OG008-0.2± 0.75
OG001
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.
OG002
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.
Units
Counts
Participants
OG0008
OG00122
OG00262
Title
Denominators
Categories
Head Control: Unable to Maintain Head Upright
Title
Measurements
OG00013
OG00186
OG00234
Head Control: Wobbles
Title
Measurements
OG00013
OG0019
OG00218
Head Control: All the Time Maintained Upright
Title
Measurements
OG00075
OG0015
OG00248
Sitting: Cannot Sit
Title
Measurements
OG00013
OG001100
OG00239
Sits With Support at Hips
Title
Measurements
OG00013
OG0010
OG00219
Sitting: Props
Title
Measurements
OG0000
OG0010
OG0028
Sitting: Stable sit
Title
Measurements
OG00013
OG0010
OG00219
Sitting: Pivots (rotates)
Title
Measurements
OG00063
OG0010
OG00215
Ability to Kick: No kicking
Title
Measurements
OG0000
OG00168
OG00218
Ability to Kick: Kick horizontally legs do not lift
Title
Measurements
OG00013
OG00132
OG00229
Ability to Kick: Upward (vertically)
Title
Measurements
OG0000
OG0010
OG00210
Ability to Kick: Touches leg
Title
Measurements
OG0000
OG0010
OG00211
Ability to Kick: Touches toes
Title
Measurements
OG00088
OG0010
OG00232
Rolling: No Rolling
Title
Measurements
OG00025
OG00191
OG00227
Rolling: Rolling to Side
Title
Measurements
OG0000
OG0019
OG00237
Rolling: Prone to Supine
Title
Measurements
OG00013
OG0010
OG0025
Rolling: Supine to Prone
Title
Measurements
OG00063
OG0010
OG00231
Crawling: Does not Lift Head
Title
Measurements
OG00063
OG001100
OG00281
Crawling: On Elbow
Title
Measurements
OG0000
OG0010
OG00213
Crawling: On Outstretched Hand
Title
Measurements
OG0000
OG0010
OG0022
Crawling: Crawling Flat on Abdomen
Title
Measurements
OG00013
OG0010
OG0023
Crawling: Crawling on Hands and Knees
Title
Measurements
OG00025
OG0010
OG0022
Standing: Does not support weight
Title
Measurements
OG00038
OG001100
OG00279
Standing: Supports weight
Title
Measurements
OG00013
OG0010
OG00211
Standing: Stands with support
Title
Measurements
OG00025
OG0010
OG00210
Standing: Stands unaided
Title
Measurements
OG00025
OG0010
OG0020
Walking: No Walking
Title
Measurements
OG00075
OG001100
OG00295
Walking: Bouncing
Title
Measurements
OG0000
OG0010
OG0020
Walking: Cruising (Walks Holding on)
Title
Measurements
OG00013
OG0010
OG0025
Walking: Walking Independently
Title
Measurements
OG00013
OG0010
OG0020
Voluntary Grasp:No Grasp
Title
Measurements
OG0000
OG00114
OG0026
Voluntary Grasp:Uses Whole Hand
Title
Measurements
OG0000
OG00155
OG00218
Voluntary Grasp:Index Finger&Thumb;Immature Grasp
Title
Measurements
OG0000
OG00114
OG00221
Voluntary Grasp:Pincer Grasp
Title
Measurements
OG000100
OG00118
OG00252
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00342
OG00420
OG00583
OG0068
OG00712
OG00825
Title
Denominators
Categories
Title
Measurements
OG0000
OG0016
OG00211
OG0031
OG0040
OG0051
OG0060
OG0072
OG0080
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00542
OG00683
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG00013
OG00120
OG00261
OG00311
OG00420
OG00542
OG00683
OG00725
OG0088
Participants who entered the study after receiving sham procedures in the double-blind study ISIS 396443-CS3B received 4 loading doses of nusinersen administered by IT injection on Days 1, 15, 29, and 64 (±1 day) followed by maintenance doses of nusinersen approximately every 4 months according to the MMDR dosing schedule.
OG002
Infantile SMA Onset CS3B Previous ISIS 396443
Participants who entered the study after receiving nusinersen in the double-blind study ISIS 396443-CS3B received 3 sham procedures on Days 1, 15, and 64 and 1 loading dose of nusinersen administered by IT injection on Day 29 (±1 day) followed by maintenance doses of nusinersen approximately every 4 months according to the MMDR dosing schedule.
Units
Counts
Participants
OG00013
OG00124
OG00265
Title
Denominators
Categories
Baseline
ParticipantsOG00013
ParticipantsOG00124
ParticipantsOG00265
Title
Measurements
OG00047.4± 13.09
OG00117.3± 9.71
OG00238.8± 9.43
Change at Day 2198
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG00229
Title
Measurements
OG000
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00117
OG00249
OG00312
OG00420
OG00523
OG00642
OG00781
OG0088
Title
Denominators
Categories
Baseline
ParticipantsOG00013
ParticipantsOG00117
ParticipantsOG00249
ParticipantsOG00312
ParticipantsOG00420
ParticipantsOG00523
ParticipantsOG00642
ParticipantsOG00781
ParticipantsOG0088
Title
Measurements
OG00014.5± 13.75
OG0010.0± 0.0
OG0027.3± 6.88
OG003
Change at MMDR Day 1800
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG0038
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00011
OG0016
OG00218
OG00311
OG00420
OG00518
OG00642
OG00780
OG0088
Title
Denominators
Categories
Baseline
ParticipantsOG00011
ParticipantsOG0016
ParticipantsOG00218
ParticipantsOG00311
ParticipantsOG00420
ParticipantsOG00518
ParticipantsOG00642
ParticipantsOG00780
ParticipantsOG0088
Title
Measurements
OG00011.8± 7.24
OG0011.7± 1.63
OG00210.3± 6.05
OG003
Change at MMDR Day 1800
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG00212
ParticipantsOG0036
Units
Counts
Participants
OG0001
OG00113
Title
Denominators
Categories
Baseline
ParticipantsOG0001
ParticipantsOG00113
Title
Measurements
OG0000± NADue to 1 evaluable participant, SD was not estimated
OG001253.3± 182.74
Change at Day 2670
ParticipantsOG0001
ParticipantsOG0016
Title
Measurements
OG000156.5± NADue to 1 evaluable participant, SD was not estimated
OG001
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00010
OG00110
OG00241
OG0038
OG00413
OG00518
OG00620
OG00745
OG0085
Title
Denominators
Categories
At least one contracture at any location
Title
Measurements
OG0009
OG00110
OG00236
OG0038
OG00413
OG0058
OG00619
OG00744
OG0085
Severe contractures in any of the five locations
Title
Measurements
OG0003
OG0013
OG00216
OG003
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00122
OG00260
OG0038
OG00420
OG00523
OG00633
OG00762
OG0086
Title
Denominators
Categories
PA: Baseline
ParticipantsOG00013
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG0038
ParticipantsOG00419
ParticipantsOG00522
ParticipantsOG00633
ParticipantsOG00762
ParticipantsOG0086
Title
Measurements
OG0003.02± 2.207
OG0010.35± 0.517
OG0021.91± 1.367
OG003
PA: Change at MMDR Day 1800
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG00234
ParticipantsOG0036
UA: Baseline
ParticipantsOG00013
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG0038
UA: Change at MMDR Day 1800
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG00235
ParticipantsOG0036
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0004
OG0017
OG00214
OG0036
OG0044
OG0051
OG0068
OG00723
OG0082
Title
Denominators
Categories
Title
Measurements
OG00024.2± 2.86
OG00119.9± 6.99
OG00229.4± 6.38
OG00318.8± 10.92
OG00418.8± 8.54
OG00523.1± 0
OG00623.7± 7.06
OG00724.6± 10.60
OG008-10.3± 57.63
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0009
OG00111
OG00243
OG0038
OG00413
OG00520
OG00620
OG00750
OG0086
Title
Denominators
Categories
Title
Measurements
OG0009.8± 3.48
OG0017.7± 4.39
OG0029.3± 3.25
OG0039.5± 7.04
OG00415.1± 5.96
OG00513.8± 14.88
OG00615.4± 8.05
OG00715.2± 7.38
OG00811.7± 8.09
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0008
OG00111
OG00243
OG0036
OG0040
OG0050
OG0069
OG00714
OG0086
Title
Denominators
Categories
Title
Measurements
OG0005.7± 27.30
OG001-5.3± 28.97
OG0020.3± 28.55
OG003-0.7± 25.32
OG0060.9± 17.22
OG00720.2± 28.15
OG0084.0± 33.11
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00122
OG00260
OG00312
OG00420
OG00524
OG00642
OG00781
OG0088
Title
Denominators
Categories
Title
Measurements
OG00085
OG0010
OG00272
OG00333
OG00465
OG00567
OG00660
OG00751
OG00825
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00012
OG00122
OG00260
OG00312
OG00420
OG00524
OG00642
OG00781
OG0088
Title
Denominators
Categories
SWS:Achieved at Baseline&Maintained to Last Visit
Title
Measurements
OG0005
OG0010
OG00216
OG0033
OG00413
OG00523
OG00627
OG00758
OG0085
SWS:Inability at Baseline, Achieved at Last visit
Title
Measurements
OG0003
OG0010
OG00211
OG003
HKC:Achieved at Baseline&Maintained to Last Visit
Title
Measurements
OG0001
OG0010
OG0020
OG003
HKC: Inability at Baseline, Achieved at Last Visit
Title
Measurements
OG0000
OG0010
OG0024
OG003
SWA:Achieved at Baseline&Maintained to Last Visit
Title
Measurements
OG0001
OG0010
OG0023
OG003
SWA:Inability at Baseline, Achieved at Last Visit
Title
Measurements
OG0000
OG0010
OG0023
OG003
WA: Achieved at Baseline&Maintained to Last Visit
Title
Measurements
OG0001
OG0010
OG0020
OG003
WA: Inability at Baseline, Achieved at Last Visit
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00012
OG00122
OG00260
OG00312
OG00420
OG00524
OG00642
OG00781
OG0088
Title
Denominators
Categories
SA: Achieved at Baseline & Maintained to Last Visit
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG00519
OG0061
OG0072
OG0081
SA: Inability at Baseline, Achieved at Last Visit
Title
Measurements
OG0000
OG0010
OG0022
OG003
WWA: Achieved at Baseline & Maintained to Last Visit
Title
Measurements
OG0001
OG0010
OG0021
OG003
WWA: Inability at Baseline, Achieved at Last Visit
Title
Measurements
OG0000
OG0010
OG0022
OG003
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Day 1-360
ParticipantsOG00013
ParticipantsOG00124
ParticipantsOG00265
ParticipantsOG00312
ParticipantsOG00420
ParticipantsOG00525
ParticipantsOG00642
ParticipantsOG00783
ParticipantsOG0088
Title
Measurements
OG0002
OG00112
OG00230
OG003
Day 361-720
ParticipantsOG00013
ParticipantsOG00122
ParticipantsOG00261
ParticipantsOG00312
Day 721-1080
ParticipantsOG00012
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG00312
Day 1081-1440
ParticipantsOG00012
ParticipantsOG00121
ParticipantsOG00259
ParticipantsOG00311
Day 1441-1800
ParticipantsOG00012
ParticipantsOG00118
ParticipantsOG00255
ParticipantsOG00310
Day 1801-2160
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00252
ParticipantsOG0036
Day 2161-2520
ParticipantsOG00013
ParticipantsOG00110
ParticipantsOG00239
ParticipantsOG0030
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Day 1-360
ParticipantsOG00013
ParticipantsOG00124
ParticipantsOG00265
ParticipantsOG00312
ParticipantsOG00420
ParticipantsOG00525
ParticipantsOG00642
ParticipantsOG00783
ParticipantsOG0088
Title
Measurements
OG0006
OG00126
OG00289
OG003
Day 361-720
ParticipantsOG00013
ParticipantsOG00122
ParticipantsOG00261
ParticipantsOG00312
Day 721-1080
ParticipantsOG00012
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG00312
Day 1081-1440
ParticipantsOG00012
ParticipantsOG00121
ParticipantsOG00259
ParticipantsOG00311
Day 1441-1800
ParticipantsOG00012
ParticipantsOG00118
ParticipantsOG00255
ParticipantsOG00310
Day 1801-2160
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00252
ParticipantsOG0036
Day 2161-2520
ParticipantsOG00013
ParticipantsOG00110
ParticipantsOG00239
ParticipantsOG0030
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00122
OG00260
OG00312
OG00420
OG00524
OG00642
OG00781
OG0088
Title
Denominators
Categories
Day 1-360
ParticipantsOG00013
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG00312
ParticipantsOG00420
ParticipantsOG00524
ParticipantsOG00642
ParticipantsOG00781
ParticipantsOG0088
Title
Measurements
OG0000.00(0.00 to 2.0)
OG0011.11(0.00 to 16.7)
OG0020.28(0.00 to 22.8)
OG003
Day 361-720
ParticipantsOG00012
ParticipantsOG00122
ParticipantsOG00260
ParticipantsOG00312
Day 721-1080
ParticipantsOG00012
ParticipantsOG00120
ParticipantsOG00259
ParticipantsOG00312
Day 1081-1440
ParticipantsOG00012
ParticipantsOG00117
ParticipantsOG00254
ParticipantsOG00311
Day 1441-1800
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG00250
ParticipantsOG00310
Day 1801-2160
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG00219
ParticipantsOG0036
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0008
OG00111
OG00242
OG0038
OG00412
OG00510
OG00635
OG00767
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00242
ParticipantsOG0038
ParticipantsOG00412
ParticipantsOG00510
ParticipantsOG00635
ParticipantsOG00767
ParticipantsOG0085
Title
Measurements
OG00022.7± 17.86
OG00116.6± 13.38
OG00234.8± 18.43
OG003
Change at MMDR day 1800
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG00226
ParticipantsOG0035
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0008
OG00111
OG00242
OG0037
OG0048
OG00511
OG00620
OG00750
OG0086
Title
Denominators
Categories
S: Physical Functioning Report
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00228
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG00511
ParticipantsOG00620
ParticipantsOG00750
ParticipantsOG0085
Title
Measurements
OG00037.1± 11.26
OG00122.4± 31.52
OG00247.5± 25.31
OG003
S: Emotional Functioning Report
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00229
ParticipantsOG0037
S: Social Functioning
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00228
ParticipantsOG0037
S: School/Work Functioning Report
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00228
ParticipantsOG0035
P: Physical Functioning Report
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00242
ParticipantsOG0037
P: Emotional Functioning Report
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00242
ParticipantsOG0037
P: Social Functioning Report
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00242
ParticipantsOG0037
P: School/Work Functioning Report
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00242
ParticipantsOG0037
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00010
OG00111
OG00238
OG0038
OG0048
OG0059
OG00618
OG00747
OG0086
Title
Denominators
Categories
Feeding/Grooming/Dressing TS: Change MMDR Day1800
Title
Measurements
OG00014.2± 21.56
OG0010.6± 2.01
OG00218.5± 22.07
OG0039.2± 15.91
OG0042.1± 14.82
OG0050.6± 2.43
OG0064.6± 18.90
OG0075.9± 12.07
OG0082.8± 7.72
Sitting/Play TS: Change at MMDR Day 1800
Title
Measurements
OG0000.8± 10.29
OG001-0.4± 14.91
OG0025.5± 28.01
OG003
Transfers TS: Change at MMDR Day 1800
Title
Measurements
OG0000.4± 7.24
OG0010.7± 1.62
OG0020.0± 12.32
OG003
Mobility TS: Change at MMDR Day 1800
Title
Measurements
OG000-2.3± 14.93
OG0010.5± 1.72
OG0027.5± 22.52
OG003
Time TS: Change at MMDR Day 1800
Title
Measurements
OG0004.4± 19.78
OG0016.8± 24.76
OG002-0.7± 22.60
OG003
Emotion TS: Change at MMDR Day 1800
Title
Measurements
OG0005.0± 14.80
OG0016.3± 15.82
OG002-2.1± 20.98
OG003
Finance TS: Change at MMDR Day 1800
Title
Measurements
OG000-1.0± 17.29
OG0017.3± 20.66
OG002-4.1± 22.17
OG003
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00312
OG00420
OG00525
OG00642
OG00783
OG0088
Title
Denominators
Categories
Disease-related hospitalization
Title
Measurements
OG0006
OG0019
OG00227
OG0035
OG0049
OG0050
OG00613
OG00723
OG0083
Disease-related AEs
Title
Measurements
OG00011
OG00121
OG00260
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00013
OG00124
OG00265
OG00342
OG00483
OG0058
OG00620
OG00712
OG00825
Title
Denominators
Categories
Title
Measurements
OG000100
OG00179.16
OG00287.69
OG00397.61
OG00498.79
OG005100
OG006100
OG00791.66
OG008100
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0041 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0082 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0061 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0082 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
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EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0061 affected25 at risk
EG0071 affected42 at risk
EG0083 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0072 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0063 affected25 at risk
EG0070 affected42 at risk
EG0082 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0081 affected83 at risk
0 affected
12 at risk
EG0041 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0084 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0082 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0074 affected42 at risk
EG0082 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0061 affected25 at risk
EG0070 affected42 at risk
EG0083 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0052 affected20 at risk
EG0060 affected25 at risk
EG0076 affected42 at risk
EG0088 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
0 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0073 affected42 at risk
EG0086 affected83 at risk
2 affected
12 at risk
EG0040 affected8 at risk
EG0050 affected20 at risk
EG0060 affected25 at risk
EG0070 affected42 at risk
EG0080 affected83 at risk
1 affected
12 at risk
EG0040 affected8 at risk
EG0051 affected20 at risk
EG0060 affected25 at risk
EG0071 affected42 at risk
EG0081 affected83 at risk
1
OG0040
OG0050
OG0061
OG0072
OG0080
5
OG00410
OG0053
OG00621
OG00739
OG0085
0
OG0040
OG0050
OG0061
OG0070
OG0080
3
OG0040
OG0050
OG0062
OG0070
OG0080
2
OG0040
OG0051
OG0062
OG0073
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0065
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0042
OG0051
OG0061
OG0074
OG0080
0
OG0041
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0051
OG0060
OG0071
OG0081
0
OG0041
OG0051
OG0061
OG0073
OG0080
0
OG0040
OG0050
OG0061
OG0072
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0072
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0051
OG0060
OG0070
OG0080
1
OG0042
OG0051
OG0064
OG0077
OG0081
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0064
OG0076
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0062
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0073
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0072
OG0080
0
OG0040
OG0050
OG0061
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0072
OG0080
0
OG0040
OG0050
OG0061
OG0072
OG0080
2
OG0040
OG0050
OG0060
OG0071
OG0080
1
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0051
OG0061
OG0072
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0072
OG0080
1
OG0040
OG0052
OG0062
OG0078
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
-6.0
± NA
Since only one participant was evaluable at Day 2198, the standard deviation (SD) could not be estimated.