Study of ALXN2050 in Adult Participants With Generalized... | NCT05218096 | Trialant
NCT05218096
Sponsor
Alexion Pharmaceuticals, Inc.
Status
Terminated
Last Update Posted
Jan 9, 2025Actual
Enrollment
70Actual
Phase
Phase 2
Conditions
Generalized Myasthenia Gravis
Myasthenia Gravis
Interventions
ALXN2050
Placebo
Countries
United States
Canada
Germany
Italy
Serbia
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT05218096
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ALXN2050-MG-201
Secondary IDs
ID
Type
Description
Link
2021-001229-26
EudraCT Number
Brief Title
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
Acronym
Not provided
Organization
Alexion Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision
Expanded Access Info
No
Start Date
Apr 27, 2022Actual
Primary Completion Date
Nov 30, 2023Actual
Completion Date
Apr 3, 2024Actual
First Submitted Date
Dec 16, 2021
First Submission Date that Met QC Criteria
Jan 28, 2022
First Posted Date
Feb 1, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Nov 26, 2024
Results First Submitted that Met QC Criteria
Jan 6, 2025
Results First Posted Date
Jan 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
Jan 6, 2025
Last Update Posted Date
Jan 9, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alexion Pharmaceuticals, Inc.INDUSTRY
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
This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG).
Safety will be monitored throughout the study.
Detailed Description
The study consists of a blinded 8-week Primary Evaluation Period (PEP) and a blinded 26-week Extended Treatment Period (ETP). After completion of 34 weeks of treatment, participants will enter an Open-label Extension (OLE) Period for up to 1.5 years.
Conditions Module
Conditions
Generalized Myasthenia Gravis
Myasthenia Gravis
Keywords
ALXN2050
gMG
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
70Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ALXN2050: 180 mg
Experimental
Participants will receive ALXN2050.
Drug: ALXN2050
ALXN2050: 120 mg
Experimental
Participants will receive ALXN2050.
Drug: ALXN2050
Placebo
Placebo Comparator
Participants will receive placebo followed by ALXN2050.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ALXN2050
Drug
Oral tablet.
ALXN2050: 120 mg
ALXN2050: 180 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction Of ≥ 2 Points In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function.
Baseline through Week 8
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8
The QMG Score for Disease Severity is an objective evaluation of therapy for MG and is based on quantitative testing of sentinel muscle groups. The QMG instrument consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The QMG total score was calculated as the sum of the scores of the 13 items and ranges from 0 to 39, with higher scores indicating more severe disease. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline QMG total score as a covariate were used to calculate the least square (LS) mean and the standard error.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with MG at least 3 months (90 days) prior to the date of the Screening Visit. Confirmation of MG must be made via the following:
Positive serologic test for anti AChR antibodies at the Screening Visit, and
Abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, or
Positive response to an AChEI test (eg, edrophonium chloride test), or
Improvement of signs or symptoms related to MG during treatment with an oral AChEI, as determined by the treating physician
Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at the Screening Visit.
MG-ADL total score must be ≥ 5 (with at least 50% of the score attributed to non-ocular elements) at the Screening Visit and at randomization (Day 1).
Participants receiving treatment with protocol-specified immunosuppressive therapies, corticosteroids, or acetylcholinesterase inhibitors must have been receiving treatment and on a stable dose prior to the date of the Screening Visit, with no changes to the regimen expected during screening, the PEP, and/or the ETP.
Exclusion Criteria:
Estimated glomerular filtration rate ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to the Screening Visit.
Any untreated thymic malignancy, carcinoma, or thymoma. Participants with a history of treated thymic malignancy or carcinoma are eligible for enrollment if they meet pre-specified conditions outlined in the protocol.
Clinical features consistent with Clinical Deterioration at the time of the Screening Visit or at any time during the Screening Period prior to randomization (Day 1).
Use of the following within the time periods specified below:
Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.
Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.
Sacca F, Gialdini G, Howard JF Jr, Vu TH, Meisel A, Peric S, Lunemann JD, Sgarzi M, Shaibani A, Bril V, Yeh JH, Reyes-Garrido V, Liao S, Metais C, van der Valk RJP; ALXN2050-MG-201 Investigators. Efficacy and Safety of Vemircopan in Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. 2026 Jun 1;83(6):544-553. doi: 10.1001/jamaneurol.2026.0902.
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
This study did not meet its primary efficacy endpoint and was early terminated by the Sponsor.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
FG001
Group 2: ALXN2050 120 mg BID
Periods
Title
Milestones
Reasons Not Completed
Primary Evaluation
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
Nov 15, 2023
Nov 26, 2024
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
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Masking of treatment allocation will be observed until at least Week 34.
Who Masked
ParticipantCare ProviderInvestigator
ACH-0145228 (formerly)
Placebo
Drug
Oral tablet.
Placebo
Baseline, Week 8
Change From Baseline In MG-ADL Total Score At Week 8
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline MG-ADL total score as a covariate were used to calculate the LS mean and the standard error.
Baseline, Week 8
Change From Baseline In Quality Of Life In Neurological Disorders (Neuro-QoL) Fatigue Score At Week 8
The Neuro-QoL Fatigue questionnaire is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each item is scored on a scale of 1-5, with 1 indicating "never" and 5 indicating "sometimes". The Neuro-QoL Fatigue score was calculated as the sum of the scores of the 19 items and ranges from 19-95, with higher scores indicating greater fatigue and greater impact of MG on activities. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline Neuro-QoL Fatigue score as a covariate were used to calculate the LS mean and the standard error.
Baseline, Week 8
Aurora
Colorado
80045
United States
Research Site
Boca Raton
Florida
33487
United States
Research Site
Port Charlotte
Florida
33952
United States
Research Site
Tampa
Florida
33612
United States
Research Site
Lexington
Kentucky
40508
United States
Research Site
New Hyde Park
New York
11042
United States
Research Site
Chapel Hill
North Carolina
27514
United States
Research Site
Charlotte
North Carolina
28207
United States
Research Site
West Chester
Ohio
45069
United States
Research Site
Portland
Oregon
97239
United States
Research Site
Springfield
Oregon
97477
United States
Research Site
Philadelphia
Pennsylvania
19104
United States
Research Site
Nashville
Tennessee
37232
United States
Research Site
Houston
Texas
77030
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
Milwaukee
Wisconsin
53228
United States
Research Site
Edmonton
Alberta
T6G 2R7
Canada
Research Site
London
Ontario
N6A 4L6
Canada
Research Site
Toronto
Ontario
M5G 2C4
Canada
Research Site
Berlin
10117
Germany
Research Site
Bochum
44791
Germany
Research Site
Düsseldorf
40225
Germany
Research Site
Hamburg
20246
Germany
Research Site
Leipzig
04103
Germany
Research Site
Bergamo
24127
Italy
Research Site
Milan
20133
Italy
Research Site
Naples
80131
Italy
Research Site
Pisa
56100
Italy
Research Site
Roma
00168
Italy
Research Site
Rome
00189
Italy
Research Site
Udine
33100
Italy
Research Site
Belgrade
11000
Serbia
Research Site
Niš
18000
Serbia
Research Site
Daegu
41404
South Korea
Research Site
Seoul
03080
South Korea
Research Site
Seoul
06351
South Korea
Research Site
Yangsan
50612
South Korea
Research Site
Barcelona
08036
Spain
Research Site
Madrid
28046
Spain
Research Site
Málaga
29010
Spain
Research Site
Murcia
30120
Spain
Research Site
Seville
41009
Spain
Research Site
Hualien City
97002
Taiwan
Research Site
Taipei
11101
Taiwan
Research Site
Taoyuan City
Taiwan
Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
FG002
Group 3: Placebo
Participants received placebo BID during the primary evaluation period.
FG003
Group 3a: Placebo/ALXN2050 180 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
FG004
Group 3b: Placebo/ALXN2050 120 mg BID
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
FG00028 subjects
FG00114 subjects
FG00228 subjects
FG0030 subjects
FG0040 subjects
Received at Least 1 Dose of Study Intervention
Full Analysis Set
FG00028 subjects
FG00114 subjects
FG00228 subjects
FG0030 subjects
FG0040 subjects
Entered Extended Treatment Period
FG00027 subjects
FG00114 subjects
FG00226 subjects
FG0030 subjects
FG0040 subjects
Re-randomized to ALXN2050 120 mg BID
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
Re-randomized to ALXN2050 180 mg BID
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00027 subjects
FG00114 subjects
FG00226 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Extended Treatment
Type
Comment
Milestone Data
STARTED
FG00027 subjects
FG00114 subjects
FG0020 subjectsAll placebo participants completing the Primary Evaluation period were re-randomized to Group 3a and Group 3b.
FG00313 subjectsAll Group 3 participants completing the Primary Evaluation period were re-randomized to Group 3a and Group 3b.
FG00413 subjectsAll Group 3 participants completing the Primary Evaluation period were re-randomized to Group 3a and Group 3b.
Received at Least 1 Dose of Study Intervention
Full Analysis Set
FG00027 subjects
FG00114 subjects
FG0020 subjects
FG003
Entered Open-label Extension Period
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0038 subjects
FG004
COMPLETED
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG00011 subjects
FG0018 subjects
FG0020 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Clinical Deterioration
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG003
Open-label Extension
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0038 subjects
FG0049 subjects
Received at Least 1 Dose of Study Intervention
Full Analysis Set
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00016 subjects
FG0016 subjects
FG0020 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set: all participants who received at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
BG001
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
BG002
Group 3: Placebo/ALXN2050
Participants received placebo BID during the primary evaluation period, followed by re-randomization to Group 3a and Group 3b, after which they received ALXN2050 180 mg BID and ALXN205 120 mg BID, respectively, during the extended treatment period and open-label extension period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00114
BG00228
BG00370
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
BG00049.0± 15.55
BG00155.9± 13.02
BG00258.2± 16.45
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00110
BG002
Ethnicity (NIH/OMB)
National Institutes of Health/Office of Management & Budget (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Baseline MG-ADL Total Score
Myasthenia Gravis Activities of Daily Living (MG-ADL)
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0009.4± 2.23
BG0019.0± 2.96
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
Percentage Of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction Of ≥ 2 Points In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function.
Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure
Posted
Number
90% Confidence Interval
percentage of participants
Baseline through Week 8
ID
Title
Description
OG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
OG001
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
OG002
Group 3: Placebo
Participants received placebo BID during the primary evaluation period.
Units
Counts
Participants
OG00016
OG0018
OG00218
Title
Denominators
Categories
Title
Measurements
OG00057.1(40.0 to 73.1)
OG00157.1(32.5 to 79.4)
OG00264.3(47.0 to 79.2)
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
OG002
Barnard's Unconditional Exact Test
0.6797
Difference
-7.1
2-Sided
90
-28.8
15.0
CI calculated using the Chan and Zhang method.
Other
Difference
OG001
OG002
Barnard's Unconditional Exact Test
Secondary
Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8
The QMG Score for Disease Severity is an objective evaluation of therapy for MG and is based on quantitative testing of sentinel muscle groups. The QMG instrument consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The QMG total score was calculated as the sum of the scores of the 13 items and ranges from 0 to 39, with higher scores indicating more severe disease. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline QMG total score as a covariate were used to calculate the least square (LS) mean and the standard error.
Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
OG001
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
Secondary
Change From Baseline In MG-ADL Total Score At Week 8
The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline MG-ADL total score as a covariate were used to calculate the LS mean and the standard error.
Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
OG001
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
Secondary
Change From Baseline In Quality Of Life In Neurological Disorders (Neuro-QoL) Fatigue Score At Week 8
The Neuro-QoL Fatigue questionnaire is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each item is scored on a scale of 1-5, with 1 indicating "never" and 5 indicating "sometimes". The Neuro-QoL Fatigue score was calculated as the sum of the scores of the 19 items and ranges from 19-95, with higher scores indicating greater fatigue and greater impact of MG on activities. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline Neuro-QoL Fatigue score as a covariate were used to calculate the LS mean and the standard error.
Full Analysis Set: all participants who received at least 1 dose of study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 8
ID
Title
Description
OG000
Group 1: ALXN2050 180 mg BID
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
OG001
Group 2: ALXN2050 120 mg BID
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
OG002
Time Frame
Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
Description
Safety Set: all randomized participants who received at least 1 dose of study intervention.
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
Group 1: ALXN2050 180 mg BID (Primary Evaluation)
Participants received 180 mg ALXN2050 BID during the primary evaluation period.
0
28
1
28
17
28
EG001
Group 2: ALXN2050 120 mg BID (Primary Evaluation)
Participants received 120 mg ALXN2050 BID during the primary evaluation period.
0
14
1
14
7
14
EG002
Group 3: Placebo (Primary Evaluation)
Participants received placebo BID during the primary evaluation period.
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
0
13
2
13
10
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG0030 events0 affected27 at risk
EG0041 events1 affected14 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected13 at risk
Myocardial infarction
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Sinus arrest
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Herpes simplex meningitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Salmonella sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
Adverse event only affected female participants.
EG0000 events0 affected18 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 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 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG0030 events0 affected27 at risk
EG0040 events0 affected14 at risk
EG0051 events1 affected13 at risk
EG0060 events0 affected13 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Macrocytosis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Spontaneous haematoma
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Thyroid cyst
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0005 events5 affected28 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Chest discomfort
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Facial discomfort
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected28 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Swelling face
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected28 at risk
EG003
Vaccination site erythema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0023 events3 affected28 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Demyelination
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG00012 events8 affected28 at risk
EG0010 events0 affected14 at risk
EG0026 events5 affected28 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
Adverse events affected only male participants.
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
Adverse events affected only female participants.
EG0000 events0 affected18 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected28 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected28 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Haematoma
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected28 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected28 at risk
EG003
Spider vein
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected28 at risk
EG003
This study did not meet its primary efficacy endpoint and was early terminated by the Sponsor.