A Study to Assess the Safety, Tolerability, and Effect on... | NCT04494256 | Trialant
NCT04494256
Sponsor
Biogen
Status
Terminated
Last Update Posted
Oct 9, 2025Actual
Enrollment
99Actual
Phase
Phase 1Phase 2
Conditions
Amyotrophic Lateral Sclerosis
Interventions
BIIB105
Placebo
Countries
United States
Canada
Italy
Netherlands
Protocol Section
Identification Module
NCT ID
NCT04494256
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
275AS101
Secondary IDs
ID
Type
Description
Link
2020-000207-36
EudraCT Number
Brief Title
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
Official Title
A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene
Acronym
ALSpire
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor's decision
Expanded Access Info
No
Start Date
Sep 28, 2020Actual
Primary Completion Date
Aug 13, 2024Actual
Completion Date
Aug 13, 2024Actual
First Submitted Date
Jul 30, 2020
First Submission Date that Met QC Criteria
Jul 30, 2020
First Posted Date
Jul 31, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 12, 2025
Results First Submitted that Met QC Criteria
Sep 23, 2025
Results First Posted Date
Oct 9, 2025Actual
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 23, 2025
Last Update Posted Date
Oct 9, 2025Actual
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The ALSpire Study is a clinical trial evaluating the investigational drug BIIB105 in adults living with amyotrophic lateral sclerosis (ALS).
The ALSpire Study consists of two parts:
Part 1: 6-month placebo-controlled study. During Part 1, participants are randomly assigned to receive either BIIB105 or placebo in a 3:1 or 2:1 ratio (depending on the participant's assigned Cohort).
Part 2: up to 3-year long-term open-label extension. During Part 2, all participants receive BIIB105.
The objectives of the study are to evaluate:
The safety and tolerability of BIIB105 in people with ALS
What the body does to BIIB105 (also called "pharmacokinetics")
What BIIB105 does to the body (also called "pharmacodynamics")
Whether BIIB105 can slow the worsening of clinical function
Detailed Description
About BIIB105:
- BIIB105 is an investigational drug designed to reduce the levels of a protein called ATXN2. It is administered intrathecally (via a procedure called lumbar puncture).
Conditions Module
Conditions
Amyotrophic Lateral Sclerosis
Keywords
Not provided
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
99Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Cohort A
Experimental
Participants with ALS will receive BIIB105 Dose 1, intrathecally (IT), as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Drug: BIIB105
Part 1: Cohort B
Experimental
Participants with ALS will receive BIIB105 Dose 2, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Drug: BIIB105
Part 1: Cohort C1
Experimental
Participants with ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Drug: BIIB105
Part 1: Cohort D1
Experimental
Participants with ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Drug: BIIB105
Part 1: Cohort C2
Experimental
Participants with polyQ-ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIIB105
Drug
Administered as specified in the treatment arm.
Part 1: Cohort A
Part 1: Cohort B
Part 1: Cohort C1
Part 1: Cohort C2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.
From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)
Part 2: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.
From first dose of the study in Part 2 up to end of follow up period in Part 2 (up to Day 1184)
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Serum Concentrations of BIIB105
Pre-dose and 1, 2, 4, 6 hours post-dose on days 1, 15, 29, 57, 85,113, 141, 169 and on days 2, 8, 92, and 176
Part 1: CSF Concentrations of BIIB105
Pre-dose on Days 1, 15, 29, 57, 85, 113, 141, 169, and on days 92, 130, 175, and 176
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Part 1:
Ability of the participant to understand the purpose and risks of the study and indicate informed consent, and the ability of the participant or the participant's legally authorized representative, to provide signed and dated informed consent and authorization to use protected health information in accordance with national and local privacy regulations.
No known presence or family history of mutations in the superoxide dismutase 1 (SOD1) or fused in sarcoma (FUS) genes.
Participants in Cohorts A, B, C1 and D1, must meet the laboratory-supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 [Brooks 2000]). Participants in Cohort C2 and D2, must meet any of the prior conditions, but may also only meet clinically possible criteria for diagnosing ALS, or exhibit weakness attributable to ALS in the presence of ataxin-2 protein (ATXN2) intermediate repeats.
In participants in Cohorts C2 and D2, confirmed intermediate cytosine-adenine-guanine/cytosine-adenine-adenine (CAG/CAA) repeat expansion in the ataxin-2 (ATXN2) gene as defined by at least 1 allele carrying 30 to 33 CAG/CAA repeats.
Slow vital capacity (SVC) criteria:
In participants in Cohorts A, B, C1, and D1, SVC ≥60% of predicted value as adjusted for sex, age, and height (from the sitting position).
In participants in Cohort C2 and D2, SVC ≥50% of predicted value as adjusted for sex, age, and height (from the sitting position).
If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that it should be discontinued for medical reasons, in which case it may not be restarted during the study.
Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.
Screening values of coagulation parameters including platelet count, international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) should be within normal ranges.
Has an informant/caregiver who, in the Investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities at screening.
Part 2:
Ability of the participant to understand the purpose and risks of the study and indicate informed consent, and the ability of the participant or the participant's legally authorized representative to provide signed and dated informed consent and authorization to use protected health information in accordance with national and local privacy regulations
Participants must have completed Study NCT04494256 Part 1 through Week 25 (Day 175 Visit for Cohorts A, B, C1, C2; Day 176 Visit for Cohorts D1, D2). This inclusion criterion does not apply to a participant if Part 1 was terminated by the Sponsor before the participant reached Week 25.
Participants from Cohorts A, B, C1, and C2 must have a washout of ≥16 weeks between the last dose of study treatment received in Study NCT04494256 Part 1 and the first dose of BIIB105 received in Study NCT04494256 Part 2. Participants from Cohorts D1 and D2 do not require a washout period.
If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that it should be discontinued for medical reasons, in which case it may not be restarted during the study.
Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.
Screening values of coagulation parameters including platelet count, INR, PT, and aPTT should be within normal ranges.
Key Exclusion Criteria
Part 1:
History or positive test result at Screening for human immunodeficiency virus (HIV).
Current hepatitis C infection.
Current hepatitis B infection.
History of alcohol or substance abuse ≤6 months of Screening that would limit participation in the study, as determined by the Investigator.
Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period.
Presence of tracheostomy.
In participants from Cohorts A, B, C1, and D1, history of myocardial infarction, as determined by the Investigator.
In participants from Cohorts A, B, C1, and D1, poorly controlled type 1 or 2 diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥8% during Screening.
In participants in Cohorts A, B, and C1, prescreening ALSFRS-R slope >-0.4 points/month, where prescreening ALSFRS-R slope is defined as: (ALSFRS-R score at Screening - 48) / (months from date of symptom onset to date of Screening). This criterion is not applicable for Cohorts C2, D1, and D2.
Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs) or biological agent within 1 month or 5 half-lives of study agent, whichever is longer, before Screening.
Treatment with an approved disease-modifying therapy for ALS other than riluzole or edaravone within 1 month or 5 half-lives of therapy, whichever is longer, before completion of screening.
Treatment with an antiplatelet or anticoagulant therapy that cannot safely be interrupted for lumbar puncture (LP) according to local standard of care and/or institutional guidelines, in the opinion of the Investigator or Prescriber.
Female participants who are pregnant or currently breastfeeding and those intending to become pregnant during the study.
Part 2:
History or positive test result at Screening for HIV. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for HIV during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.
Current hepatitis C infection. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for hepatitis C during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.
Current hepatitis B infection. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for hepatitis B during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.
History of alcohol or substance abuse ≤ 6 months of Screening that would limit participation in the study, as determined by the Investigator.
Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period.
In participants from Cohorts A, B, C1, and D1, history of myocardial infarction, as determined by the Investigator.
In participants from Cohorts A, B, C1, and D1, poorly controlled type 1 or 2 diabetes mellitus defined as HbA1c ≥8% during Screening.
Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs; excluding BIIB105) or biological agent within 1 month or 5 half-lives of study agent, whichever is longer, before Screening.
Treatment with an antiplatelet or anticoagulant therapy that cannot safely be interrupted for LP according to local standard of care and/or institutional guidelines, in the opinion of the Investigator or Prescriber.
Female participants who are pregnant or currently breastfeeding and those intending to become pregnant during the study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Kim G, Nakayama L, Blum JA, Akiyama T, Boeynaems S, Chakraborty M, Couthouis J, Tassoni-Tsuchida E, Rodriguez CM, Bassik MC, Gitler AD. Genome-wide CRISPR screen reveals v-ATPase as a drug target to lower levels of ALS protein ataxin-2. Cell Rep. 2022 Oct 25;41(4):111508. doi: 10.1016/j.celrep.2022.111508.
A total of 99 participants were randomized in Part 1 (placebo-controlled) of study to receive BIIB105 or placebo, of which 80 participants completed Part 1. A total of 70 eligible participants who completed Part 1 were enrolled into Part 2 (open-label) of study to receive BIIB105. Part 2 of study was terminated early based on Sponsor's decision.
Recruitment Details
Participants diagnosed with amyotrophic lateral sclerosis (ALS) and ALS associated with ataxin-2 (ATXN2) polyCAG expansion (polyQALS) took part in the study at investigational sites in the United States, Netherlands, Canada and Italy from 28 September 2020 to 13 August 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Pooled Placebo 1+2
Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Periods
Title
Milestones
Reasons Not Completed
Part 1: Double Blinded Period
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
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
Sep 7, 2023
Aug 12, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: BIIB105
Part 1: Cohort D2
Experimental
Participants with polyQ-ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Drug: BIIB105
Part 1: Cohorts A-D2: Placebo
Placebo Comparator
Participants with ALS and polyQ-ALS for Cohorts A, B, C1 and C2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days, and participants with ALS and polyQ-ALS for Cohorts D1 and D2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.
Drug: Placebo
Part 2: Cohorts A-C2: Open-Label
Experimental
Participants who complete Cohorts A, B, C1, and C2 will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed up to thirty-eight maintenance doses, on up to thirty-eight later days.
Drug: BIIB105
Part 2: Cohorts D1, D2: Open-Label
Experimental
Participants who complete Cohorts D1 and D2 will have a blinded Loading Dose Period, during which those who received placebo in Part 1 will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, while those who received BIIB105 in Part 1 will receive 2 loading doses of BIIB105 Dose 4, IT, on Days 1 and one later day, and placebo on Day 15. After the blinded Loading Dose Period, participants will receive BIIB105 Dose 4 up to thirty-eight maintenance doses, on up to thirty-eight later days.
Drug: BIIB105
Part 1: Cohort D1
Part 1: Cohort D2
Part 2: Cohorts A-C2: Open-Label
Part 2: Cohorts D1, D2: Open-Label
Placebo
Drug
Administered as specified in the treatment arm.
Part 1: Cohorts A-D2: Placebo
Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf)
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was reported following dose 1 as planned.
Day 1
Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)
AUClast was reported following dose 1 as planned.
Day 1
Part 1: Maximum Observed Serum Concentration (Cmax)
Days 1, 15, 29, 57, 85, 113, 141 and 169
Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)
Days 1, 15, 29, 57, 85, 113, 141 and 169
Part 1: Elimination Half-Life (t1/2) in Serum
Elimination half-life (t1/2) was reported following dose 1 as planned.
Day 1
Part 1: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.
Days 29, 57, 85, 113, 130 (For cohorts A, B, C1 and C2)/141 (For cohorts D1 and D2), 169 (For cohorts A, B, C1 and C2)/175 (For cohorts D1 and D2) and 241
Integrated Part 1 and Part 2: CSF PK Concentration of BIIB105
Predose on Days 1,15,29,57,85 and on Days 1,15,29,57,85,113,141,169.176,197,210,225,253,281,309,337,365,393,420,448,476,504,532,560,588,616,644,672,700,726,728
Integrated Part 1 and Part 2: Serum Concentration of BIIB105
Up to Day 176
Integrated Part 1 and Part 2: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.
Integrated Part 1 and Part 2: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)
Vital capacity was measured by means of the slow vital capacity (SVC) test using a facemask with the participant sitting upright. SVC was determined by performing at least 3 trials. If the difference between the two highest values of the three trials was ≥10%, then up to 5 trials were performed. The highest percent predicted SVC value at each visit was used for the analysis. Here, baseline is defined as Part 1 day 1 value prior to the study drug. As specified in SAP, change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the analysis of covariance (ANCOVA) model. Negative change from baseline indicates decrease in lung function.
Baseline, Day 281
Integrated Part 1 and Part 2: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
The ALSFRS-R is a questionnaire that measured degree of impairment in 4 functional domains: respiratory function, bulbar function, gross motor skills, and fine motor skills. Each domain consists of 3 items, each scored from 0 to 4, with higher scores representing better function. Each domain score can have maximum score of 12 calculated as the sum of scores of 3 items for that domain and the total possible score for ALSFRS-R is 48. The total score is the sum of the 4 functional domain scores or all individual item scores if no missing item scores are present. Here, baseline is defined as Part 1 day 1 value prior to the study drug Negative change from baseline indicates disease progression. As specified in SAP change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the ANCOVA model.
Baseline, Day 281
Integrated Part 1 and Part 2: Change From Baseline in Muscle Strength as Measured by Handheld Dynamometry (HHD) Megascore
Quantitative muscle strength was evaluated using HHD, which tested the isometric strength of multiple muscles using standard participant positioning. Approximately 8 muscle groups were examined (per each side) in both upper and lower extremities. The muscle strength values were normalized to Z scores as (post-baseline measurements -mean)/SD and averaged to provide HHD overall megascore. The overall megascore was created by averaging Z scores, if no more than 14 (≤ 14) measures are missing. A Z-score (also called a standard score) is a way to describe how far and in what direction a data point is from the mean of the dataset (in this case, positive values indicate strength and negative values indicate weakness). A Z-score of 0 indicates the population mean, and a positive score indicates muscle strength. A negative change from baseline indicated decreased muscle strength.
Baseline, Day 281
Integrated Part 1 and Part 2: Time to Death or Permanent Ventilation
Time to death or permanent ventilation is defined as the time from first dose to death or permanent ventilation ( ≥ 22 hours of mechanical ventilation [invasive or noninvasive] per day for ≥ 21 consecutive days), whichever comes first. Participants who did not meet the endpoint definition were censored on the date of participant's last contact in Part 1 or Part 2. Time to death or permanent ventilation data was summarized using Kaplan-Meier curves based on randomization in Part 1.
Baseline up to Day 1184
Integrated Parts 1 and 2: Time to Death
Time to death was defined as the time from first dose to death.
Baseline up to Day 1184
Integrated Part 1 and Part 2: Time to Death, Incorporating Post-Study Withdrawal or Study Completion Vital Status Data
Up to Day 1184
La Jolla
California
92037
United States
Stanford Neuromuscular Research Center
Palo Alto
California
94305
United States
University of Colorado Hospital - Neuroscience Center -Anschutz Medical Campus
Aurora
Colorado
80045
United States
Georgetown University
Washington D.C.
District of Columbia
20007-2113
United States
Mayo Clinic Florida
Jacksonville
Florida
32224
United States
Orlando Health
Orlando
Florida
32806
United States
The Emory Clinic
Atlanta
Georgia
30322
United States
ALS Clinic - Department of Neurology, Neuromuscular Division, Johns Hopkins University, School of Medicine
Baltimore
Maryland
21218
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Washington University, School of Medicine
St Louis
Missouri
63110
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Houston Methodist Neurological Institute
Houston
Texas
77030
United States
University of Utah
Salt Lake City
Utah
84132
United States
Montreal Neurological Institute-Hospital
Montreal
Quebec
H3A 2B4
Canada
A.O.U. Città della salute e della scienza di Torino
Torino
Italy
UMC Utrecht
Utrecht
3584 CX
Netherlands
FG001
Part 1: Cohort A: BIIB105 5 Milligrams (mg)
Participants with ALS received 3 loading doses of BIIB105 5mg, intrathecally (IT), administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
FG002
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
FG003
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
FG004
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
FG005
Part 2: BIIB105 60 mg
Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.
FG006
Part 2: BIIB105 120 mg
Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.
FG00028 subjects
FG0016 subjects
FG0026 subjects
FG00311 subjects
FG00448 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG00026 subjects
FG0016 subjects
FG0025 subjects
FG0039 subjects
FG00434 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG00414 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
Disease Progression - As Defined by the Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
SubjectWithdrawal-VisitBurden/SchedulingConflict
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Subject - Other
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Reason Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2: Open Label Period
Type
Comment
Milestone Data
STARTED
Not all participants that completed Part 1 started Part 2.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00519 subjects
FG00651 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The part 1 full analysis set (FAS) population included all randomized participants who received at least 1 dose of study treatment in Part 1.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Pooled Placebo 1+2
Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
BG001
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
BG002
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
BG003
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
BG004
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG0016
BG0026
BG00311
BG00448
BG00599
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.9± 11.15
BG00160.5± 5.72
BG00249.3± 17.84
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0010
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
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.
Part 1 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 1.
Posted
Count of Participants
Participants
From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)
ID
Title
Description
OG000
Part 1: Pooled Placebo 1+2
Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
OG001
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG003
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG004
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG00028
OG0016
OG0026
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00028
OG0016
OG0026
OG003
Primary
Part 2: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.
Part 2 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 2.
Posted
Count of Participants
Participants
From first dose of the study in Part 2 up to end of follow up period in Part 2 (up to Day 1184)
ID
Title
Description
OG000
Part 2: BIIB105 60 mg
Participants from cohorts A-C2, who received 5, 20 and 60 mg BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) Visit in Part 1 received BIIB105 60 mg in Part 2.
OG001
Part 2: BIIB105 120 mg
Participants from Cohorts D1 and D2 randomised to BIIB105 120 mg and placebo in Part 1 and completed Week 25 (Day 176) Visit in Part 1 received BIIB105 at 120 mg in Part 2.
Secondary
Part 1: Serum Concentrations of BIIB105
The Part 1 pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or cerebrospinal fluid (CSF) BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure (OM) at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Pre-dose and 1, 2, 4, 6 hours post-dose on days 1, 15, 29, 57, 85,113, 141, 169 and on days 2, 8, 92, and 176
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Secondary
Part 1: CSF Concentrations of BIIB105
The Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on Days 1, 15, 29, 57, 85, 113, 141, 169, and on days 92, 130, 175, and 176
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
Secondary
Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf)
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was reported following dose 1 as planned.
Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour*nanogram per milliliter (h*ng/mL)
Day 1
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Secondary
Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)
AUClast was reported following dose 1 as planned.
Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Secondary
Part 1: Maximum Observed Serum Concentration (Cmax)
Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Days 1, 15, 29, 57, 85, 113, 141 and 169
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
Secondary
Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)
Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified timepoint.
Posted
Median
Full Range
hour
Days 1, 15, 29, 57, 85, 113, 141 and 169
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
Secondary
Part 1: Elimination Half-Life (t1/2) in Serum
Elimination half-life (t1/2) was reported following dose 1 as planned.
Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. ''Overall number of participants (n)' signifies number of participants evaluable for this OM.
Posted
Median
Full Range
hour
Day 1
ID
Title
Description
OG000
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG001
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG002
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
Secondary
Part 1: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.
The Part 1 pharmacodynamic (PD) population included participants who received at least 1 dose of study treatment and have at least 1 available postdose evaluation of the respective PD endpoint in the study in Part 1. 'Number analyzed (n)' indicates the number of participants evaluable for the OM at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Days 29, 57, 85, 113, 130 (For cohorts A, B, C1 and C2)/141 (For cohorts D1 and D2), 169 (For cohorts A, B, C1 and C2)/175 (For cohorts D1 and D2) and 241
ID
Title
Description
OG000
Part 1: Pooled Placebo 1+2
Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
OG001
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
Secondary
Integrated Part 1 and Part 2: CSF PK Concentration of BIIB105
Integrated Part 1 & 2=Part 1 PK population.Overall number of participants analyzed=number of participants evaluable for OM analysis.Number analyzed=number of participants evaluable at specified timepoint.Assessment was planned upto Day 1093 however,no assessments were conducted after Day 729 due to early termination.Treatment groups for integrated analysis of Parts 1 & 2 were planned for Early-start BIIB105 120 mg & Placebo/Delayed-start BIIB105,& results are reported for these treatment groups.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Predose on Days 1,15,29,57,85 and on Days 1,15,29,57,85,113,141,169.176,197,210,225,253,281,309,337,365,393,420,448,476,504,532,560,588,616,644,672,700,726,728
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Secondary
Integrated Part 1 and Part 2: Serum Concentration of BIIB105
Assessments were planned upto Day 1009 for this OM;however no assessments were conducted after Day 176 due to early termination.Serum concentrations of BIIB105 were not estimable for Integrated Parts 1 & 2.Data collected for serum PK concentrations for Parts 1 & 2 are reported in OM #3 and #20(post-hoc)respectively.Treatment groups for integrated analysis of Parts 1 & 2 were planned for Early-start BIIB105 120 mg & Placebo/Delayed-start BIIB105,& results are reported for these treatment groups.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Up to Day 176
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Secondary
Integrated Part 1 and Part 2: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline
Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.
Integrated Parts 1 and 2=Part 1 PD population. Number analyzed indicates the number of participants evaluable for the OM at the specified timepoint. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Secondary
Integrated Part 1 and Part 2: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)
Vital capacity was measured by means of the slow vital capacity (SVC) test using a facemask with the participant sitting upright. SVC was determined by performing at least 3 trials. If the difference between the two highest values of the three trials was ≥10%, then up to 5 trials were performed. The highest percent predicted SVC value at each visit was used for the analysis. Here, baseline is defined as Part 1 day 1 value prior to the study drug. As specified in SAP, change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the analysis of covariance (ANCOVA) model. Negative change from baseline indicates decrease in lung function.
Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Least Squares Mean
Standard Error
percent predicted
Baseline, Day 281
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Secondary
Integrated Part 1 and Part 2: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score
The ALSFRS-R is a questionnaire that measured degree of impairment in 4 functional domains: respiratory function, bulbar function, gross motor skills, and fine motor skills. Each domain consists of 3 items, each scored from 0 to 4, with higher scores representing better function. Each domain score can have maximum score of 12 calculated as the sum of scores of 3 items for that domain and the total possible score for ALSFRS-R is 48. The total score is the sum of the 4 functional domain scores or all individual item scores if no missing item scores are present. Here, baseline is defined as Part 1 day 1 value prior to the study drug Negative change from baseline indicates disease progression. As specified in SAP change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the ANCOVA model.
Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Day 281
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
Secondary
Integrated Part 1 and Part 2: Change From Baseline in Muscle Strength as Measured by Handheld Dynamometry (HHD) Megascore
Quantitative muscle strength was evaluated using HHD, which tested the isometric strength of multiple muscles using standard participant positioning. Approximately 8 muscle groups were examined (per each side) in both upper and lower extremities. The muscle strength values were normalized to Z scores as (post-baseline measurements -mean)/SD and averaged to provide HHD overall megascore. The overall megascore was created by averaging Z scores, if no more than 14 (≤ 14) measures are missing. A Z-score (also called a standard score) is a way to describe how far and in what direction a data point is from the mean of the dataset (in this case, positive values indicate strength and negative values indicate weakness). A Z-score of 0 indicates the population mean, and a positive score indicates muscle strength. A negative change from baseline indicated decreased muscle strength.
Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Mean
Standard Deviation
z-score
Baseline, Day 281
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
Secondary
Integrated Part 1 and Part 2: Time to Death or Permanent Ventilation
Time to death or permanent ventilation is defined as the time from first dose to death or permanent ventilation ( ≥ 22 hours of mechanical ventilation [invasive or noninvasive] per day for ≥ 21 consecutive days), whichever comes first. Participants who did not meet the endpoint definition were censored on the date of participant's last contact in Part 1 or Part 2. Time to death or permanent ventilation data was summarized using Kaplan-Meier curves based on randomization in Part 1.
Integrated data for Part 1 and Part 2 was analyzed based on the FAS population defined for Part 1. Part 1 FAS population included all randomized participants who received at least 1 dose of study treatment in Part 1 and 2. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Median
95% Confidence Interval
weeks
Baseline up to Day 1184
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Secondary
Integrated Parts 1 and 2: Time to Death
Time to death was defined as the time from first dose to death.
Integrated data for Part 1 and Part 2 was analyzed based on the FAS population defined for Part 1. Part 1 FAS population included all randomized participants who received at least 1 dose of study treatment in Part 1 and 2. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Median
95% Confidence Interval
weeks
Baseline up to Day 1184
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Secondary
Integrated Part 1 and Part 2: Time to Death, Incorporating Post-Study Withdrawal or Study Completion Vital Status Data
As per the changes to the protocol-specified analyses mentioned in the SAP, time to death, incorporating post-study withdrawal or study completion vital status data was not performed as post-study withdrawal vital status data was not collected at the time of this analysis. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.
Posted
Up to Day 1184
ID
Title
Description
OG000
Early-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Participants
Post-Hoc
Part 2: Serum Concentration of BIIB105
The PK analysis population is defined as all randomized participants who received at least 1 dose of study treatment and have at least 1 postdose serum and/or CSF BIIB105 measurement. 'Number analyzed' indicates the number of participants evaluable at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Days 1, 169, 337, 505 and 673
ID
Title
Description
OG000
Part 2: BIIB105 60 mg
Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.
OG001
Part 2: BIIB105 120 mg
Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.
Units
Counts
Participants
OG000
Time Frame
From first dose of the study drug up to end of follow up period in Part 1 (up to Day 260) and Part 2 (up to Day 1184)
Description
The Part 1 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 1. The Part 2 safety analysis population included all participants who received at least 1 dose of study treatment in Part 2.
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
Part 1: Pooled Placebo 1+2
Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
0
28
5
28
27
28
EG001
Part 1: Cohort A: BIIB105 5 mg
Participants with ALS received 3 loading doses of BIIB105 5mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
0
6
0
6
6
6
EG002
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
0
6
0
6
6
6
EG003
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
0
11
1
11
11
11
EG004
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received BIIB105 120 mg, IT, as 3 loading doses administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
0
48
7
48
47
48
EG005
Part 2: BIIB105 60 mg
Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.
4
19
7
19
19
19
EG006
Part 2: BIIB105 120 mg
Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.
2
51
14
51
45
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
Food poisoning
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Seronegative arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Amyotrophic lateral sclerosis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cerebral venous sinus thrombosis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Medical device site burn
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Swelling face
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Vaccination site pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG00014 affected28 at risk
EG0011 affected6 at risk
EG0024 affected6 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal procedural complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Neurological procedural complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0007 affected28 at risk
EG0013 affected6 at risk
EG0021 affected6 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG00015 affected28 at risk
EG0015 affected6 at risk
EG0024 affected6 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Shoulder fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Stoma site discharge
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Csf protein increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Csf white blood cell count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected6 at risk
EG0023 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0006 affected28 at risk
EG0011 affected6 at risk
EG0022 affected6 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0007 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Brain fog
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Clonus
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Cluster headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG00012 affected28 at risk
EG0013 affected6 at risk
EG0024 affected6 at risk
EG003
Hemihypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Menstrual headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Pleocytosis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Post-traumatic headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0004 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Nodular rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Study terminated because of sponsor's decision.
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 with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0006
OG0016
OG00211
OG00348
Title
Denominators
Categories
Day 1: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Day 1: 1 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Day 1: 2 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Day 1: 4 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Day 1: 6 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00348
Day 8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00344
Day 15: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00344
Day 15: 1 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 15: 2 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 15: 4 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 15: 6 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 29: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00343
Day 29: 1 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00342
Day 29: 2 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00342
Day 29: 4 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00342
Day 29: 6 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 57: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 57: 1 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 57: 2 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 57: 4 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 57: 6 HR post-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 85: Pre-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00341
Day 85: 1 HR post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 85: 2 HR post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 85: 4 HR post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 85: 6 HR post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 92
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG0036
Day 113: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 113: 1 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 113: 2 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 113: 4 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 113: 6 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 141: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00338
Day 141: 1 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Day 141: 2 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Day 141: 4 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Day 141: 6 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
Day 169: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
Day 169: 1 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00335
Day 169: 2 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00335
Day 169: 4 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
Day 169: 6 HR post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Day 176
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00333
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0006
OG0016
OG00211
OG00348
Title
Denominators
Categories
Day 1 : Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Day 15 : Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00344
Day 29 : Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00343
Day 57 : Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00342
Day 85 : Pre-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 92
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG0030
Day 113
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00340
Day 130
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG0030
Day 141
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00338
Day 169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00337
Day 175
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0030
Day 176
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0002
OG0015
OG00210
OG00342
Title
Denominators
Categories
Title
Measurements
OG000934.22± 52.89
OG0013546.89± 53.50
OG00211258.45± 14.57
OG00324466.44± 30.24
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0006
OG0016
OG00211
OG00344
Title
Denominators
Categories
Title
Measurements
OG000574.59± 79.16
OG0013239.40± 52.73
OG00211758.68± 21.12
OG00324289.70± 30.50
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0006
OG0016
OG00211
OG00348
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Title
Measurements
OG00052.18± 123.13
OG001227.80± 73.20
OG002644.10± 55.31
OG003
Day 15
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 29
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 57
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 85
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 113
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 141
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
Day 169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0006
OG0016
OG00211
OG00348
Title
Denominators
Categories
Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00347
Title
Measurements
OG0004.2(2 to 6)
OG0014.2(2 to 6)
OG0025.8(2 to 23)
OG003
Day 15
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00341
Day 29
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 57
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00340
Day 85
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG00340
Day 113
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
Day 141
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
Day 169
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00336
OG003
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG0002
OG0015
OG00210
OG00342
Title
Denominators
Categories
Title
Measurements
OG00014.0(5 to 23)
OG00126.6(17 to 62)
OG00241.7(33 to 62)
OG00339.8(22 to 82)
OG002
Part 1: Cohort B: BIIB105 20 mg
Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG003
Part 1: Cohorts C1+C2: BIIB105 60 mg
Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.
OG004
Part 1: Cohorts D1 + D2: BIIB105 120 mg
Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.
Units
Counts
Participants
OG00028
OG0016
OG0026
OG00311
OG00447
Title
Denominators
Categories
Day 29
ParticipantsOG00028
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00311
ParticipantsOG00445
Title
Measurements
OG0001.04± 20.32
OG0011.05± 8.47
OG0020.83± 47.1
OG003
Day 57
ParticipantsOG00028
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00311
Day 85
ParticipantsOG00027
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00310
Day 113
ParticipantsOG00017
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 130 (A,B,C1,C2)/Day 141 (D1,D2)
ParticipantsOG00025
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00310
Day 169 (A,B,C1,C2)/Day 175 (D1,D2)
ParticipantsOG00024
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0039
Day 214
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Units
Counts
Participants
OG00048
OG00117
Title
Denominators
Categories
Day 1 : Pre-dose
ParticipantsOG00048
ParticipantsOG0010
Title
Measurements
OG0000.13± 0.00
Day 1
ParticipantsOG0000
ParticipantsOG00117
Title
Measurements
OG0010.15± 37.88
Day 15 : Pre-dose
ParticipantsOG00044
ParticipantsOG0010
Title
Measurements
OG00014.54± 82.48
Day 15
ParticipantsOG0001
ParticipantsOG00117
Title
Measurements
OG00031.04
OG001
Day 29: Pre-dose
ParticipantsOG00043
ParticipantsOG0010
Title
Measurements
OG00017.53± 95.18
Day 29
ParticipantsOG0000
ParticipantsOG00117
Title
Measurements
OG00118.62± 93.41
Day 57 : Pre-dose
ParticipantsOG00042
ParticipantsOG0010
Title
Measurements
OG00010.29± 79.90
Day 57
ParticipantsOG0000
ParticipantsOG00114
Title
Measurements
OG0019.72± 49.08
Day 85 : Pre-dose
ParticipantsOG00040
ParticipantsOG0010
Title
Measurements
OG00014.06± 77.42
Day 85
ParticipantsOG0000
ParticipantsOG00113
Title
Measurements
OG00114.54± 63.76
Day 113
ParticipantsOG00040
ParticipantsOG00111
Title
Measurements
OG00017.08± 86.41
OG001
Day 141
ParticipantsOG00038
ParticipantsOG0018
Title
Measurements
OG00017.91± 84.83
OG001
Day 169
ParticipantsOG00037
ParticipantsOG0017
Title
Measurements
OG00018.88± 74.23
OG001
Day 176
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG00017.35± 0.04
Day 197
ParticipantsOG00032
ParticipantsOG0015
Title
Measurements
OG00024.88± 57.69
OG001
Day 210
ParticipantsOG00031
ParticipantsOG0010
Title
Measurements
OG00049.04± 67.88
Day 225
ParticipantsOG00033
ParticipantsOG0015
Title
Measurements
OG00024.14± 63.21
OG001
Day 253
ParticipantsOG00033
ParticipantsOG0015
Title
Measurements
OG00023.54± 62.86
OG001
Day 281
ParticipantsOG00027
ParticipantsOG0012
Title
Measurements
OG00026.51± 73.96
OG001
Day 309
ParticipantsOG00025
ParticipantsOG0012
Title
Measurements
OG00027.14± 63.54
OG001
Day 337
ParticipantsOG00020
ParticipantsOG0012
Title
Measurements
OG00031.34± 71.84
OG001
Day 365
ParticipantsOG00016
ParticipantsOG0010
Title
Measurements
OG00030.16± 62.35
Day 393
ParticipantsOG00011
ParticipantsOG0012
Title
Measurements
OG00023.56± 31.29
OG001
Day 420
ParticipantsOG00011
ParticipantsOG0011
Title
Measurements
OG00025.84± 42.82
OG001
Day 448
ParticipantsOG0009
ParticipantsOG0011
Title
Measurements
OG00023.53± 40.75
OG001
Day 476
ParticipantsOG0007
ParticipantsOG0011
Title
Measurements
OG00030.87± 28.29
OG001
Day 504
ParticipantsOG0006
ParticipantsOG0010
Title
Measurements
OG00028.24± 38.06
Day 532
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG00026.73± 44.19
Day 560
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00026.42± 36.82
Day 588
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG00040.26± 68.00
Day 616
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG00024.69± 109.22
Day 644
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00021.15± 39.95
Day 672
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG00030.75± 48.18
Day 700
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG00023.85± 1.63
Day 726
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG00028.22
Day 728
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG00026.28
Participants
OG00048
OG00117
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData were not estimable due to values being below the lower limit of quantification
OG001NA± NAData were not estimable due to values being below the lower limit of quantification
Units
Counts
Participants
OG00047
OG00119
Title
Denominators
Categories
Day 29
ParticipantsOG00045
ParticipantsOG00119
Title
Measurements
OG0001.15± 72.72
OG0011.03± 22.35
Day 57
ParticipantsOG00044
ParticipantsOG00119
Title
Measurements
OG0001.03± 21.7
OG001
Day 85
ParticipantsOG00041
ParticipantsOG00118
Title
Measurements
OG0000.99± 19.62
OG001
Day 113
ParticipantsOG00040
ParticipantsOG00117
Title
Measurements
OG0001.01± 21.77
OG001
Day 141
ParticipantsOG00039
ParticipantsOG00116
Title
Measurements
OG0001.03± 41.35
OG001
Day 169
ParticipantsOG00039
ParticipantsOG00116
Title
Measurements
OG0001.06± 24.92
OG001
Day 197
ParticipantsOG00031
ParticipantsOG00113
Title
Measurements
OG0001.08± 28.28
OG001
Day 225
ParticipantsOG00031
ParticipantsOG00113
Title
Measurements
OG0001.12± 38.42
OG001
Day 253
ParticipantsOG00026
ParticipantsOG00112
Title
Measurements
OG0001.15± 28.4
OG001
Day 281
ParticipantsOG00022
ParticipantsOG00110
Title
Measurements
OG0001.14± 26.57
OG001
Day 309
ParticipantsOG00017
ParticipantsOG0019
Title
Measurements
OG0001.07± 31.81
OG001
Day 337
ParticipantsOG00012
ParticipantsOG0016
Title
Measurements
OG0001.05± 38.67
OG001
Day 365
ParticipantsOG00011
ParticipantsOG0014
Title
Measurements
OG0000.99± 32.42
OG001
Day 393
ParticipantsOG0009
ParticipantsOG0014
Title
Measurements
OG0000.95± 48.05
OG001
Day 421
ParticipantsOG0009
ParticipantsOG0013
Title
Measurements
OG0000.92± 36.61
OG001
Day 449
ParticipantsOG0007
ParticipantsOG0013
Title
Measurements
OG0000.82± 28.9
OG001
Day 477
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0000.85± 23.15
OG001
Day 505
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0000.77± 25.18
OG001
Day 533
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0000.78± 14.58
OG001
Day 561
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG0000.65± 14.63
Day 589
ParticipantsOG0003
ParticipantsOG0012
Title
Measurements
OG0000.77± 39.28
OG001
Day 617
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000.80± 38.48
OG001
Day 645
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0000.76± 52.68
Day 673
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0000.66± 30.22
Day 701
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG0000.54
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Participants
OG00048
OG00119
Title
Denominators
Categories
Title
Measurements
OG000-14.49± 4.093
OG001-14.41± 7.133
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
=0.9924
ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.
Least square (LS) mean difference
-0.1
Standard Error of the Mean
7.84
2-Sided
95
-15.47
15.32
Superiority
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Participants
OG00048
OG00119
Title
Denominators
Categories
Title
Measurements
OG000-8.46± 1.105
OG001-8.26± 1.819
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
=0.9203
ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.
LS mean difference
-0.2
Standard Error of the Mean
2.01
2-Sided
95
-4.14
3.74
Superiority
OG001
Placebo/Delayed-start BIIB105 120 mg
Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.
Units
Counts
Participants
OG00048
OG00119
Title
Denominators
Categories
Title
Measurements
OG000-0.407± 0.3918
OG001-0.439± 0.4406
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
=0.1069
ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.
LS mean difference
-0.2
Standard Error of the Mean
0.12
2-Sided
95
-0.41
0.04
Superiority
Units
Counts
Participants
OG00048
OG00119
Title
Denominators
Categories
Title
Measurements
OG000NA(72.7 to NA)Median and 95% confidence interval (CI) were not estimable due to low number events of permanent ventilation or death.
OG001NA(NA to NA)Median and 95% confidence interval (CI) were not estimable due to low number events of permanent ventilation or death.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Log rank test stratified by median baseline plasma NfL
=0.1003
Hazard Ratio (HR)
4.29
2-Sided
95
0.433
42.587
Superiority
Participants
OG00048
OG00119
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimable due to low number of events of death.
OG001NA(NA to NA)Median and 95% CI were not estimable due to low number of events of death.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Kaplan-Meier product limit method
=0.1143
Superiority
OG0000
OG0010
19
OG00151
Title
Denominators
Categories
Day 1
ParticipantsOG00019
ParticipantsOG00150
Title
Measurements
OG0000.50± 0.00
OG0011.47± 139.00
Day 169
ParticipantsOG00011
ParticipantsOG00118
Title
Measurements
OG0001.25± 186.75
OG001
Day 337
ParticipantsOG0009
ParticipantsOG0017
Title
Measurements
OG0002.46± 333.20
OG001
Day 505
ParticipantsOG0007
ParticipantsOG0011
Title
Measurements
OG0003.53± 340.11
OG001
Day 673
ParticipantsOG0003
ParticipantsOG0010
Title
Measurements
OG00018.89± 164.41
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0063 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0052 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0056 affected19 at risk
EG0067 affected51 at risk
1 affected
11 at risk
EG0047 affected48 at risk
EG0054 affected19 at risk
EG0064 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
3 affected
11 at risk
EG0045 affected48 at risk
EG0054 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0043 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0045 affected48 at risk
EG0050 affected19 at risk
EG0064 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0044 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
5 affected
11 at risk
EG0048 affected48 at risk
EG0053 affected19 at risk
EG0067 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0043 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0065 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0044 affected48 at risk
EG0054 affected19 at risk
EG0066 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0052 affected19 at risk
EG0064 affected51 at risk
0 affected
11 at risk
EG0043 affected48 at risk
EG0052 affected19 at risk
EG0066 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0063 affected51 at risk
0 affected
11 at risk
EG0043 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
1 affected
11 at risk
EG0045 affected48 at risk
EG0052 affected19 at risk
EG0062 affected51 at risk
4 affected
11 at risk
EG00418 affected48 at risk
EG0059 affected19 at risk
EG00619 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
6 affected
11 at risk
EG00415 affected48 at risk
EG0057 affected19 at risk
EG0067 affected51 at risk
1 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
2 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
7 affected
11 at risk
EG00425 affected48 at risk
EG00513 affected19 at risk
EG00620 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
3 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0063 affected51 at risk
2 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0063 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0052 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0052 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG00411 affected48 at risk
EG0054 affected19 at risk
EG0067 affected51 at risk
0 affected
11 at risk
EG0046 affected48 at risk
EG0053 affected19 at risk
EG0067 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0052 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0054 affected19 at risk
EG0066 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
4 affected
11 at risk
EG0046 affected48 at risk
EG0053 affected19 at risk
EG00611 affected51 at risk
3 affected
11 at risk
EG00412 affected48 at risk
EG0051 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
4 affected
11 at risk
EG0043 affected48 at risk
EG0052 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0049 affected48 at risk
EG0053 affected19 at risk
EG0067 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
2 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0065 affected51 at risk
2 affected
11 at risk
EG0047 affected48 at risk
EG0052 affected19 at risk
EG0067 affected51 at risk
2 affected
11 at risk
EG0042 affected48 at risk
EG0053 affected19 at risk
EG0061 affected51 at risk
2 affected
11 at risk
EG00411 affected48 at risk
EG0054 affected19 at risk
EG0067 affected51 at risk
0 affected
11 at risk
EG0046 affected48 at risk
EG0050 affected19 at risk
EG0063 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
2 affected
11 at risk
EG0048 affected48 at risk
EG0050 affected19 at risk
EG0065 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
5 affected
11 at risk
EG00428 affected48 at risk
EG0055 affected19 at risk
EG00619 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0044 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0046 affected48 at risk
EG0053 affected19 at risk
EG0064 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0044 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0052 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0062 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0053 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0065 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0051 affected19 at risk
EG0064 affected51 at risk
1 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0063 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0052 affected19 at risk
EG0063 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0042 affected48 at risk
EG0050 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0041 affected48 at risk
EG0050 affected19 at risk
EG0066 affected51 at risk
1 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0060 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0050 affected19 at risk
EG0061 affected51 at risk
0 affected
11 at risk
EG0040 affected48 at risk
EG0051 affected19 at risk
EG0061 affected51 at risk
0.00
± 0.00
Title
Measurements
OG0007.21± 500.18
OG00157.70± 285.30
OG00234.98± 465.78
OG003187.14± 351.05
Title
Measurements
OG00032.20± 177.01
OG001135.71± 109.27
OG002250.28± 101.57
OG003620.38± 132.37
Title
Measurements
OG00041.38± 125.95
OG001211.34± 68.29
OG002488.11± 51.22
OG003798.21± 86.03
Title
Measurements
OG00039.27± 102.97
OG001165.05± 60.63
OG002528.45± 61.49
OG003774.73± 60.51
Title
Measurements
OG0006.76± 65.90
OG00129.07± 76.82
OG002118.70± 103.89
OG003260.03± 67.59
Title
Measurements
OG0000.46± 18.74
OG0010.47± 36.02
OG0021.38± 74.15
OG0032.97± 43.60
Title
Measurements
OG0000.00± 0.00
OG0010.50± 20.12
OG0020.78± 52.94
OG0031.90± 43.15
Title
Measurements
OG0003.85± 172.70
OG00122.24± 226.26
OG00256.01± 489.04
OG003257.73± 290.21
Title
Measurements
OG00016.89± 111.49
OG00194.51± 140.45
OG002246.73± 142.61
OG003972.44± 110.25
Title
Measurements
OG00030.07± 74.48
OG001139.75± 137.49
OG002363.86± 77.37
OG003996.20± 83.48
Title
Measurements
OG00027.28± 106.96
OG001139.00± 98.33
OG002411.61± 49.33
OG003897.25± 78.56
Title
Measurements
OG0000.45± 24.48
OG0010.48± 28.47
OG0021.23± 64.84
OG0032.59± 59.99
Title
Measurements
OG0005.80± 117.90
OG00116.45± 557.48
OG002114.69± 226.87
OG003248.00± 152.63
Title
Measurements
OG00016.53± 121.68
OG00151.58± 602.03
OG002420.39± 116.92
OG003773.11± 95.92
Title
Measurements
OG00031.29± 120.91
OG001102.80± 200.28
OG002566.43± 71.83
OG003953.50± 80.75
Title
Measurements
OG00033.28± 127.43
OG001151.47± 87.99
OG002555.65± 52.83
OG003942.06± 69.00
Title
Measurements
OG0000.00± 0.00
OG0010.41± 21.53
OG0020.79± 80.26
OG0031.83± 69.80
Title
Measurements
OG0007.45± 275.61
OG0017.98± 159.54
OG00244.33± 615.14
OG003227.06± 214.59
Title
Measurements
OG00022.05± 153.51
OG00126.59± 107.62
OG002274.02± 128.39
OG003713.36± 122.48
Title
Measurements
OG00027.72± 123.67
OG00174.60± 85.53
OG002471.12± 95.76
OG003887.82± 105.32
Title
Measurements
OG00027.33± 105.30
OG00189.38± 74.82
OG002416.91± 94.12
OG003889.54± 89.20
Title
Measurements
OG0000.50± 0.00
OG0010.40± 33.26
OG0020.74± 64.453
OG0031.91± 113.18
Title
Measurements
OG0007.02± 111.81
OG00118.91± 240.40
OG00277.63± 142.75
OG003231.31± 236.91
Title
Measurements
OG00020.60± 95.33
OG00169.04± 265.82
OG002248.33± 84.14
OG003651.00± 127.92
Title
Measurements
OG00027.69± 111.28
OG001140.04± 91.00
OG002416.74± 80.90
OG003799.70± 89.26
Title
Measurements
OG00029.83± 119.17
OG001140.74± 50.95
OG002453.58± 74.39
OG003837.50± 73.65
Title
Measurements
OG0000.43± 23.54
OG0010.56± 47.98
OG0022.05± 92.02
OG0034.47± 64.10
Title
Measurements
OG0031.95± 59.79
Title
Measurements
OG003193.04± 198.68
Title
Measurements
OG003632.28± 91.07
Title
Measurements
OG003802.46± 91.76
Title
Measurements
OG003858.58± 86.76
Title
Measurements
OG0032.07± 80.82
Title
Measurements
OG003457.25± 162.57
Title
Measurements
OG003949.31± 120.40
Title
Measurements
OG0031044.80± 101.09
Title
Measurements
OG003996.44± 85.54
Title
Measurements
OG0032.95± 153.02
Title
Measurements
OG003288.75± 217.19
Title
Measurements
OG003702.24± 107.10
Title
Measurements
OG003816.90± 86.61
Title
Measurements
OG003683.89± 158.85
Title
Measurements
OG0036.97± 132.41
0.00
± 0.00
Title
Measurements
OG0001.93± 41.54
OG0012.71± 55.21
OG0025.75± 62.33
OG00314.54± 82.48
Title
Measurements
OG0003.53± 33.52
OG0014.32± 52.42
OG00211.53± 49.38
OG00317.53± 95.18
Title
Measurements
OG0002.32± 28.96
OG0012.65± 46.23
OG0024.82± 59.33
OG00310.29± 79.90
Title
Measurements
OG0002.37± 30.35
OG0013.18± 72.73
OG0026.50± 36.23
OG00314.06± 77.42
Title
Measurements
OG0005.01± 30.62
OG0016.28± 74.45
OG00225.51± 66.26
Title
Measurements
OG00317.08± 86.41
Title
Measurements
OG0002.09± 32.22
OG0012.45± 57.06
OG0025.42± 40.72
Title
Measurements
OG00317.91± 84.83
Title
Measurements
OG00318.88± 74.23
Title
Measurements
OG0001.16± 54.77
OG0011.16± 36.06
OG0022.68± 46.05
Title
Measurements
OG00317.35± 0.04
1019.11
± 76.61
Title
Measurements
OG00031.03± 78.23
OG001165.37± 118.45
OG002495.03± 76.73
OG0031312.42± 93.96
Title
Measurements
OG00034.11± 119.62
OG001164.15± 101.46
OG002616.02± 61.54
OG0031173.71± 75.74
Title
Measurements
OG00031.92± 136.57
OG00194.60± 75.30
OG002513.84± 98.01
OG0031052.70± 99.57
Title
Measurements
OG00031.43± 117.43
OG001168.38± 59.96
OG002476.91± 75.87
OG0031009.44± 84.68
Title
Measurements
OG003949.58± 83.69
Title
Measurements
OG0031243.75± 91.13
Title
Measurements
OG003957.24± 86.51
4.3
(1 to 24)
Title
Measurements
OG0005.0(4 to 6)
OG0015.0(2 to 6)
OG0025.9(2 to 6)
OG0034.1(1 to 6)
Title
Measurements
OG0005.8(4 to 6)
OG0015.8(2 to 6)
OG0024.2(2 to 6)
OG0034.1(2 to 6)
Title
Measurements
OG0005.8(2 to 6)
OG0015.0(4 to 6)
OG0024.2(1 to 6)
OG0034.5(1 to 6)
Title
Measurements
OG0005.1(4 to 6)
OG0014.3(4 to 6)
OG0025.8(4 to 6)
OG0035.8(2 to 6)
Title
Measurements
OG0035.3(1 to 6)
Title
Measurements
OG0034.0(1 to 6)
Title
Measurements
OG0034.1(1 to 6)
1.06
± 11.23
OG0041.15± 72.72
Participants
OG004
44
Title
Measurements
OG0001.08± 19.91
OG0010.95± 14.63
OG0020.97± 15.95
OG0031.08± 20.43
OG0041.03± 21.7
Participants
OG004
41
Title
Measurements
OG0000.99± 17.27
OG0010.99± 15.7
OG0020.98± 26.4
OG0031.11± 19.85
OG0040.99± 19.62
Participants
OG004
40
Title
Measurements
OG0001.06± 19.95
OG0041.01± 21.77
ParticipantsOG00439
Title
Measurements
OG0001.09± 20.46
OG0011.10± 8.58
OG0020.92± 40.79
OG0030.99± 30.8
OG0041.03± 41.35
ParticipantsOG00439
Title
Measurements
OG0001.10± 23.67
OG0011.02± 22.58
OG0021.10± 24.55
OG0031.08± 29.73
OG0041.06± 24.92
Participants
OG004
1
Title
Measurements
OG0041.07
12.93
± 70.31
20.70
± 56.82
24.50
± 30.13
19.32
± 36.08
24.99
± 71.18
30.52
± 13.97
21.68
± 70.34
23.79
± 8.69
30.47
± 13.01
22.11
± 16.80
15.36
± 13.95
21.91
28.43
± NA
Geometric coefficient of variation is not estimable due to less number of participants.
25.95
± NA
Geometric coefficient of variation is not estimable due to less number of participants.