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This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS.
This study will be conducted only at sites in Japan.
Eligible participants will be randomized to receive intravenous (IV) infusion of eculizumab or placebo at a 2:1 ratio. All participants will be on concomitant IV immunoglobulin G (Ig) therapy as per standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eculizumab | Experimental | Participants will receive eculizumab. |
|
| Placebo | Placebo Comparator | Participants will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab | Biological | Eculizumab will be administered via IV infusion once a week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Reaching a Hughes Functional Grade (FG) Score <=1 | The mobility of the participants was evaluated on a 7 point disability functional grade scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 metre (m) across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. The Kaplan-Meier estimate of time to event of FG<=1 is reported. Time (days) to first event=Date of first event-Date of first dose+1. Participants who discontinued early without achieving FG <= 1 were censored at the date of discontinuation. Participants who completed the study without achieving FG<=1 were censored at the date of study completion. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With A Hughes Functional Grade (FG) Score <=1 | The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. If a participant had an FG score <= 1 prior to or at Week 8 and Week 24, respectively, then the participant is considered a responder. Otherwise, participants discontinued prior to Week 8 and Week 24 or with an FG score > 1 at Week 8 and Week 24 are nonresponders, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bunkyō City | 113-8519 | Japan | |||
| Research Site |
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All participants were on concomitant intravenous immunoglobulin (IVIg) therapy as per standard of care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eculizumab | Participants received eculizumab intravenous (IV) infusion on Days 1, 8, 15, and 22. |
| FG001 | Placebo | Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2021 | Jun 6, 2023 |
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| Placebo | Drug | Placebo will be administered via IV infusion once a week for 4 weeks. |
|
| Week 8, Week 24 |
| Number of Participants With A Hughes Functional Grade Score Improvement of >=3 | The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. Participants with a change from baseline in FG score (value at Week 24 - baseline value) <= -3 were considered a responder. Participants with change from baseline > -3 and participants who discontinued prior to Week 24 were considered non-responders. | Week 24 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse event (AE) with onset on or after the first dose of the study drug. An AE is any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Day 1 up to Week 24 |
| Free Complement Component 5 in Serum | Week 24 |
| Hemolytic Complement Activity in Serum | Week 24 |
| Length of Stay in the Hospital | For participants with multiple hospitalizations, the total duration of all hospitalizations was summarized. | Up to Week 24 |
| Number of Participants Who Required Mechanical Ventilator Support | For participants with more than 1 episode of the same support, the total duration across all episodes was summarized. | Up to Week 24 |
| Concentration of Eculizumab in Serum | Up to Week 24 |
| Number of Participants With Positive Antidrug Antibodies | Up to Week 12 |
| Chiba |
| 260-0877 |
| Japan |
| Research Site | Fukuoka | 814-0180 | Japan |
| Research Site | Hiroshima | 730-8518 | Japan |
| Research Site | Kagoshima | 890-8520 | Japan |
| Research Site | Kawagoe-shi | 350-8550 | Japan |
| Research Site | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Kitakyushu-shi | 807-8555 | Japan |
| Research Site | Kobe | 650-0047 | Japan |
| Research Site | Kumamoto | 860-8556 | Japan |
| Research Site | Kurashiki-shi | 710-8602 | Japan |
| Research Site | Matsumoto-shi | 390-8621 | Japan |
| Research Site | Mitaka-shi | 181-8611 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Niigata | 951-8520 | Japan |
| Research Site | Nishinomiya-shi | 663-8501 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Sendai | 983-8520 | Japan |
| Research Site | Shimotsuga-gun | 321-0293 | Japan |
| Research Site | Ube-shi | 755-8505 | Japan |
| Research Site | Yokohama | 236-0004 | Japan |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline functional grade (FG) score and at least 1 postbaseline FG score.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eculizumab | Participants received eculizumab IV infusion on Days 1, 8, 15, and 22. |
| BG001 | Placebo | Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Time to First Reaching a Hughes Functional Grade (FG) Score <=1 | The mobility of the participants was evaluated on a 7 point disability functional grade scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 metre (m) across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. The Kaplan-Meier estimate of time to event of FG<=1 is reported. Time (days) to first event=Date of first event-Date of first dose+1. Participants who discontinued early without achieving FG <= 1 were censored at the date of discontinuation. Participants who completed the study without achieving FG<=1 were censored at the date of study completion. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Days | Up to Week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With A Hughes Functional Grade (FG) Score <=1 | The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. If a participant had an FG score <= 1 prior to or at Week 8 and Week 24, respectively, then the participant is considered a responder. Otherwise, participants discontinued prior to Week 8 and Week 24 or with an FG score > 1 at Week 8 and Week 24 are nonresponders, respectively. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. | Posted | Count of Participants | Participants | Week 8, Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With A Hughes Functional Grade Score Improvement of >=3 | The mobility of the participants was evaluated on a 7 point disability FG scale and described as Hughes FG score of 0 (Healthy, no signs or symptoms of Guillain-Barré syndrome); 1 (Minor signs or symptoms and able to run); 2 (Able to walk 5 m across an open space without assistance); 3 (Able to walk 5 m across an open space with the help of one person and waist-level walking-frame, stick, or sticks); 4 (Chairbound/bedbound: unable to walk as in 3); 5 (Requiring assisted ventilation [for at least part of day or night]) and 6 (Dead), where higher numbers indicate more severe impairment. Participants with a change from baseline in FG score (value at Week 24 - baseline value) <= -3 were considered a responder. Participants with change from baseline > -3 and participants who discontinued prior to Week 24 were considered non-responders. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse event (AE) with onset on or after the first dose of the study drug. An AE is any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Safety set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Free Complement Component 5 in Serum | Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug and who have at least 1 postdose PD sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms/milliliters | Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemolytic Complement Activity in Serum | Pharmacodynamic analysis set included all participants who received at least 1 dose of study drug and who have at least 1 postdose PD sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of hemolysis | Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay in the Hospital | For participants with multiple hospitalizations, the total duration of all hospitalizations was summarized. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. | Posted | Mean | Standard Deviation | days | Up to Week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Required Mechanical Ventilator Support | For participants with more than 1 episode of the same support, the total duration across all episodes was summarized. | Full analysis set included all randomized participants who received at least 1 dose of study drug and had a baseline FG score and at least 1 postbaseline FG score. | Posted | Count of Participants | Participants | Up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Eculizumab in Serum | Pharmacokinetic analysis set (PKAS) included all participants who received at least 1 dose of study drug and who had at least 1 postdose PK sample. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms/milliliters | Up to Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Antidrug Antibodies | Safety set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Week 12 |
|
|
Day 1 up to Week 24
Safety set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eculizumab | Participants received eculizumab IV infusion on Days 1, 8, 15, and 22. | 1 | 37 | 4 | 37 | 34 | 37 |
| EG001 | Placebo | Participants received placebo matched to eculizumab via IV infusion on Days 1, 8, 15, and 22. | 0 | 20 | 1 | 20 | 18 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hanging | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Protein urine | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals Inc. | Alexion Pharmaceuticals Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Jun 6, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C481642 | eculizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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