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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510932-36-00 | EU Trial (CTIS) Number |
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The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).
Participants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod IV - continuous regimen | Experimental | Participants receiving efgartigimod IV on a continuous regimen |
|
| Efgartigimod IV - cyclic regimen | Experimental | Participants receiving efgartigimod IV on a cyclic regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod IV | Biological | Intravenous infusions of efgartigimod |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Up to 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs and AESIs | AE : adverse event; SAE: serious adverse event; AESI: adverse event of special interest | Up to 135 weeks |
| Change From Baseline in the MG-ADL Total Score Over Time |
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Inclusion Criteria:
Exclusion Criteria:
Any other condition that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk
A thymectomy within 3 months of screening
Use of the following prior or concomitant therapies:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 10 - US0010007 | Carlsbad | California | 92011 | United States | ||
| Investigator Site 7 - US0010001 |
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The study was conducted at 31 sites that enrolled participants with anti-acetylcholine receptor antibody (AChR-Ab) seropositive gMG in 11 countries. A total of 98 participants were screened of whom 69 were randomized and treated. The results presented are based on the primary completion date. Remaining results will be reported within a year of global study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod IV - Cyclic Regimen | Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period. |
| FG001 | Efgartigimod IV - Continuous Regimen |
| 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 | May 5, 2023 | May 1, 2026 |
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The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.
| Up to 126 weeks |
| Normalized Area Under the Effect Curve (AUEC) of MG-ADL Total Score Improvement From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Up to 21 weeks |
| Characterization of MG-ADL Total Score Change From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Up to 21 weeks |
| Percentage of Participants Who Have a ≥ 2, 3, 4, or 5 Points Improvement in MG-ADL Total Score From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Up to 21 weeks |
| Percentage of Time Participants Have a Change in MG-ADL Total Score of at Least 2 Points From Baseline During Week 4 Through Week 21 | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | From week 4 to week 21 |
| Percentage of Participants Who Achieve MSE, Defined as a MG-ADL Total Score of 0 or 1 | MSE = minimal symptom expression; The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Up to 21 weeks |
| Orange |
| California |
| 92868 |
| United States |
| Investigator Site 9 - 0010006 | Boca Raton | Florida | 33487 | United States |
| Investigator Site 15 - US0010014 | Coral Springs | Florida | 33067 | United States |
| Investigator Site 16 - US0010009 | Augusta | Georgia | 30910 | United States |
| Investigator Site 8 - US0010003 | Chicago | Illinois | 60611 | United States |
| Investigator Site 6 - US0010008 | Meadows | Illinois | 60008 | United States |
| Investigator Site 12 - US0010004 | Kansas City | Kansas | 66160 | United States |
| Investigator Site 13 - US0010013 | Portland | Oregon | 97239 | United States |
| Investigator Site 17 - US0010012 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigator Site 11 - US0010011 | Austin | Texas | 78756 | United States |
| Investigator Site 14 - US0010010 | Richmond | Virginia | 23219 | United States |
| Investigator Site 26 - AT0430002 | Innsbruck | 6020 | Austria |
| Investigator Site 27 - AT0430001 | Vienna | 1090 | Austria |
| Investigator Site 28 - BE0320001 | Leuven | 3000 | Belgium |
| Investigator Site 29 - CA0019003 | London | N6A 5A5 | Canada |
| Investigator site 37 - CA0019002 | Québec | H3A 2B4 | Canada |
| Investigator Site 23 - FR0330005 | Bordeaux | 33604 | France |
| Investigator Site 24 - FR0330004 | Lille | 59000 | France |
| Investigator Site 20 - FR0330001 | Marseille | 13385 | France |
| Investigator Site 25 - FR0330003 | Nice | 06001 | France |
| Investigator site 38 - FR0330002 | Paris | 75013 | France |
| Investigator Site 2 - GEO9950002 | Tbilisi | 0112 | Georgia |
| Investigator Site 1 - GEO9950001 | Tbilisi | 0114 | Georgia |
| Investigator Site 3 - GEO9950003 | Tbilisi | 0114 | Georgia |
| Investigator Site 33 - DE0490004 | Berlin | 10117 | Germany |
| Investigator Site 36 - DE0490002 | Bochum | 44791 | Germany |
| Investigator Site 32 - DE0490001 | Essen | 45147 | Germany |
| Investigator Site 34 - DE0490005 | Hanover | 30625 | Germany |
| Investigator Site 31 - IT0390005 | Bologna | 40139 | Italy |
| Investigator Site 30 - IT0390004 | Genova | 16132 | Italy |
| Investigator Site 21 - IT0390002 | Milan | 20133 | Italy |
| Investigator site 39 - IT0390006 | Pisa | 56126 | Italy |
| Investigator Site 22 - IT0390001 | Roma | 00168 | Italy |
| Investigator Site 35 - NL0310001 | Amsterdam | 1105 | Netherlands |
| Investigator Site 5 - PL0480002 | Krakow | 31-426 | Poland |
| Investigator Site 4 - PL0480001 | Lubin | 20-093 | Poland |
| Investigator Site 18 - ES0340002 | Santiago de Compostela | A Coruña | 15706 | Spain |
| Investigator Site 19 - ES0340001 | Barcelona | 08041 | Spain |
Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration. |
| Completed Part A |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod IV - Cyclic Regimen | Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period. |
| BG001 | Efgartigimod IV - Continuous Regimen | Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration. |
| 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 | Age (years) |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | mITT (modified intent-to-treat) analysis set: all randomized participants with an MG-ADL total score at baseline and at least 1 postbaseline analysis visit at or before week 21. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Up to 21 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of AEs, SAEs and AESIs | AE : adverse event; SAE: serious adverse event; AESI: adverse event of special interest | Not Posted | Up to 135 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the MG-ADL Total Score Over Time | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | Up to 126 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Normalized Area Under the Effect Curve (AUEC) of MG-ADL Total Score Improvement From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | Up to 21 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Characterization of MG-ADL Total Score Change From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | Up to 21 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Have a ≥ 2, 3, 4, or 5 Points Improvement in MG-ADL Total Score From Baseline | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | Up to 21 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Time Participants Have a Change in MG-ADL Total Score of at Least 2 Points From Baseline During Week 4 Through Week 21 | The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | From week 4 to week 21 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve MSE, Defined as a MG-ADL Total Score of 0 or 1 | MSE = minimal symptom expression; The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment. | Not Posted | Up to 21 weeks | Participants |
Part A, up to week 21
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion. Adverse events are reported for the safety analysis set which includes all randomized participants exposed to efgartigimod IV. Any clinically significant changes occurring during the study were reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efgartigimod IV - Cyclic Regimen | Participants receiving efgartigimod IV on a cyclic regimen. The cyclic dosing regimen consisted of 3 cycles of 4 once-weekly intravenous administrations followed by a fixed 4-week intertreatment period. | 0 | 17 | 1 | 17 | 16 | 17 |
| EG001 | Efgartigimod IV - Continuous Regimen | Participants receiving efgartigimod IV on a continuous regimen. The continuous dosing regimen consisted of 4 once-weekly intravenous administrations followed by once-every-other-week administration. | 0 | 52 | 7 | 52 | 43 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BRONCHITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS CRISIS | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 28.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 28.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
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| FIBRIN D DIMER INCREASED | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 28.1 | Systematic Assessment |
| |
| CYSTOID MACULAR OEDEMA | Eye disorders | MedDRA 28.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 28.1 | Systematic Assessment |
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| VISUAL IMPAIRMENT | Eye disorders | MedDRA 28.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| ADMINISTRATION SITE EXTRAVASATION | General disorders | MedDRA 28.1 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 28.1 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| EYE INFECTION | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 28.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| SPEECH DISORDER | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
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| GLYCOSURIA | Renal and urinary disorders | MedDRA 28.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| LOWER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
| |
| MACULE | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
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| HOT FLUSH | Vascular disorders | MedDRA 28.1 | Systematic Assessment |
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| TONSILITIS | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
The results presented are based on the primary completion date, therefore only the results of part A are shown. Remaining results will be reported within a year of global study completion.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BV | +32 93103400 | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2025 | May 1, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| >= 65 years |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other |
|
| Unknown |
|
| Not Hispanic or Latino |
|