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The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection.
Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods
Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efgartigimod PH20 SC | Experimental | Patients receiving efgartigimod PH20 subcutaneous (SC) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod PH20 SC | Biological | Subcutaneous injection with efgartigimod PH20 SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of AEs, SAEs and AESIs | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. | Up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| MG-ADL Total Score Changes From Baseline | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life. The total score ranges from 0 to 24 with higher scores indicating more impairment. | Up to week 4 of the first cycle |
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Inclusion Criteria:
Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for roll over.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:
Exclusion Criteria:
The participant was discontinued early from studies ARGX-113-2001 or ARGX-113-1705, unless the reason for discontinuation from study ARGX-113-1705 was to roll over into study ARGX-113-2002.
a. Participants who, in the investigator's judgment, are not benefiting from efgartigimod IV in study ARGX-113-1705 Part B are not eligible for roll over into ARGX-113-2002.
Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of investigational medicinal product (IMP)
Has any of the following medical conditions:
Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at roll-over
Any other known autoimmune disease that, in the opinion of the investigator, would interfere with accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk
History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of investigational medicinal product (IMP).
Participants with the following cancers can be included at any time:
Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study
A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator site 6 - US0010032 | Carlsbad | California | 92011 | United States | ||
| Investigator Site 47 - US0010021 |
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All participants were adults with gMG who participated in ARGX-113-2001 or ARGX-113-1705. No randomization or blinding was performed because this was an open-label study.
This study was conducted at 47 sites that enrolled participants in 12 countries. A total of 184 participants rolled over from ARGX-113-2001 and ARGX-113-1705, of whom 180 participants were exposed to efgartigimod PH20 SC treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod PH20 SC | Patients receiving efgartigimod PH20 subcutaneous (SC) treatment; efgartigimod PH20 SC: efgartigimod for SC administration coformulated with recombinant human hyaluronidase PH20 |
| 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 | Feb 2, 2023 | Dec 10, 2025 |
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| Percent Change in Total IgG Levels From Baseline | IgG: immunoglobulin G | Up to week 4 of the first cycle |
| Percent Change in AChR-Ab From Baseline in AChR-Ab Seropositive Participants | AchR-Ab: anti-acetylcholine receptor antibodies. | Up to week 4 of the first cycle |
| Efgartigimod Serum Concentrations | Up to week 4 of the first cycle |
| Incidence of ADAs Against Efgartigimod Over Time | ADA: Anti-drug antibodies. | Up to 3.5 years |
| Incidence of NAbs Against Efgartigimod Over Time | NAbs: neutralizing antibodies | Up to 3.5 years |
| Incidence of Antibodies Against rHuPH20 Over Time | Up to 3.5 years |
| Incidence of NAbs Against rHuPH20 Over Time | NAbs: neutralizing antibodies | Up to 3.5 years |
| Changes in Total MG-QoL15r From Baseline | Myasthenia Gravis Quality of Life 15 item scale revised (MG-QoL 15r) scores range from 0 to 30 with a higher score representing more severe symptoms. | Up to week 4 of the first cycle |
| Changes in EQ-5D-5L VAS Score From Baseline | EuroQoL 5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS) scores range from 0 to 100 with a higher score representing better health. | Up to week 4 of the first cycle |
| Percent of Participants or Caregivers by Number of Training Visits Needed to be Competent to Start Self- or Caregiver-Supported Administration | Up to 3.5 years |
| Percent of Self- or Caregiver-supported Study Drug Administration Among All Study Treatment Visits at Home | Up to 3.5 years |
| Palo Alto |
| California |
| 94304 |
| United States |
| Investigator Site 45 - US0010108 | Boca Raton | Florida | 33428 | United States |
| Investigator site 4 - US0010110 | Port Charlotte | Florida | 33952 | United States |
| Investigator Site 39 - US0010006 | Tampa | Florida | 41076 | United States |
| Investigator Site 41 - US0010015 | Kansas City | Kansas | 66160 | United States |
| Investigator Site 46 - US0010111 | Amherst | New York | 14226 | United States |
| Investigator Site 38 - US0010003 | Chapel Hill | North Carolina | 27514 | United States |
| Investigator Site 44 - US0010077 | Durham | North Carolina | 27710 | United States |
| Investigator Site 42 - US0010019 | Cleveland | Ohio | 44195 | United States |
| Investigator site 7 - US0010008 | Cordova | Tennessee | 38018 | United States |
| Investigator Site 43 - US0010066 | Austin | Texas | 78759 | United States |
| Investigator Site 40 - US0010009 | San Antonio | Texas | 78229 | United States |
| Investigator site 5 - BE0320007 | Ghent | 9000 | Belgium |
| Investigator site 24 - CZ4200005 | Brno | 625 00 | Czechia |
| Investigator Site 32 - GEO9950004 | Tbilisi | K'alak'i T'bilisi | 0160 | Georgia |
| Investigator Site 33 - GEO9950016 | Tbilisi | K'alak'i T'bilisi | 016 | Georgia |
| Investigator site 2 - GEO9950002 | Tbilisi | 0112 | Georgia |
| Investigator Site 1 - GEO9950001 | Tbilisi | 0114 | Georgia |
| Investigator site 3 - GEO9950003 | Tbilisi | 0114 | Georgia |
| Investigator Site 25 - DE490006 | Berlin | 10117 | Germany |
| Investigator Site 26 - DE490009 | Münster | 48149 | Germany |
| Investigator site 10 - HU0360013 | Budapest | 1082 | Hungary |
| Investigator site 9 - HU0360012 | Budapest | 1204 | Hungary |
| Investigator site 11 - IT0390003 | Milan | 20133 | Italy |
| Investigator Site 34 - IT0390007 | Naples | 80138 | Italy |
| Investigator Site 35 - IT0390008 | Roma | 00189 | Italy |
| Investigator site 12 - JP0810002 | Chiba | Chiba-Shi | 260-8677 | Japan |
| Investigator Site 36 - JP0810055 | Sapporo | Hokkaido | 063-0005 | Japan |
| Investigator site 8 - JP0810004 | Hanamaki | Iwate | 025-0082 | Japan |
| Investigator Site 28- JP0810059 | Ōta-ku | Tokyo | 143-8541 | Japan |
| Investigator site 14 - JP0810007 | Osaka | 565-0871 | Japan |
| Investigator Site 27 - JP0810008 | Sapporo | 060 8542 | Japan |
| Investigator site 13 - JP0810005 | Sendai | 983-8520 | Japan |
| Investigator site 15 - JP0810009 | Tokyo | 160-0023 | Japan |
| Investigator site 16 - NL0310001 | Leiden | 2333 | Netherlands |
| Investigator site 17 - PL0480001 | Gdansk | 80-952 | Poland |
| Investigator site 19 - PL0480007 | Katowice | 40-123 | Poland |
| Investigator site 22 - PL0480065 | Krakow | 31-426 | Poland |
| Investigator site 18 - PL0480005 | Krakow | 31-505 | Poland |
| Investigator site 20 - PL0480018 | Lublin | 20-093 | Poland |
| Investigator site 21 - PL0480022 | Warsaw | 02-097 | Poland |
| Investigator Site 29- RU0070002 | Novosibirsk | 630087 | Russia |
| Investigator Site 30 - RU0070014 | Saint Petersburg | 194354 | Russia |
| Investigator Site 37 - ES0340021 | Barcelona | 08035 | Spain |
| Investigator Site 31 - ES0340038 | Barcelona | 08041 | Spain |
| Investigator site 23 - ES0340039 | Valencia | 46026 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod PH20 SC | Patients receiving efgartigimod PH20 subcutaneous (SC) treatment; efgartigimod PH20 SC: efgartigimod for SC administration coformulated with recombinant human hyaluronidase PH20 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| 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 | Number of AEs, SAEs and AESIs | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study | Posted | Number | events | Up to 3.5 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | MG-ADL Total Score Changes From Baseline | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life. The total score ranges from 0 to 24 with higher scores indicating more impairment. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and the respective weeks of first cycle are reported in each row. | Posted | Mean | Standard Error | score on a scale | Up to week 4 of the first cycle |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total IgG Levels From Baseline | IgG: immunoglobulin G | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Posted | Mean | Standard Error | Percent change | Up to week 4 of the first cycle |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in AChR-Ab From Baseline in AChR-Ab Seropositive Participants | AchR-Ab: anti-acetylcholine receptor antibodies. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Posted | Mean | Standard Error | Percent change | Up to week 4 of the first cycle |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Efgartigimod Serum Concentrations | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Posted | Mean | Standard Deviation | ng/mL | Up to week 4 of the first cycle |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of ADAs Against Efgartigimod Over Time | ADA: Anti-drug antibodies. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of ADA evaluable participants. | Posted | Count of Participants | Participants | Up to 3.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of NAbs Against Efgartigimod Over Time | NAbs: neutralizing antibodies | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of NAb-evaluable participants. | Posted | Count of Participants | Participants | Up to 3.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Antibodies Against rHuPH20 Over Time | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of rHuPH20 Ab evaluable participants. | Posted | Count of Participants | Participants | Up to 3.5 years |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of NAbs Against rHuPH20 Over Time | NAbs: neutralizing antibodies | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of rHuPH20 NAb-evaluable participants. | Posted | Count of Participants | Participants | Up to 3.5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Total MG-QoL15r From Baseline | Myasthenia Gravis Quality of Life 15 item scale revised (MG-QoL 15r) scores range from 0 to 30 with a higher score representing more severe symptoms. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and the respective weeks of first cycle are reported in each row. | Posted | Mean | Standard Error | score on a scale | Up to week 4 of the first cycle |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Changes in EQ-5D-5L VAS Score From Baseline | EuroQoL 5 Dimensions 5-Level (EQ-5D-5L) visual analog scale (VAS) scores range from 0 to 100 with a higher score representing better health. | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. Only participants with an assessment at baseline and week 4 of the first cycle are reported. | Posted | Mean | Standard Error | score on a scale | Up to week 4 of the first cycle |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants or Caregivers by Number of Training Visits Needed to be Competent to Start Self- or Caregiver-Supported Administration | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. The number analyzed is the total number of participants adequately trained and capable of doing self- or caregiver-supported administrations. | Posted | Number | Percent of participants | Up to 3.5 years |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Self- or Caregiver-supported Study Drug Administration Among All Study Treatment Visits at Home | Safety analysis set: all participants who were exposed to efgartigimod PH20 SC in this study. | Posted | Number | Percent | Up to 3.5 years |
|
|
3.5 years
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 PH20 SC | Patients receiving efgartigimod PH20 subcutaneous (SC) treatment; efgartigimod PH20 SC: efgartigimod for SC administration coformulated with recombinant human hyaluronidase PH20 | 5 | 180 | 55 | 180 | 167 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Rectal cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myasthenia gravis crisis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
| |
| Uterine polypectomy | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
| |
| Brachiocephalic vein stenosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BV | +32 93103400 | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2025 | Dec 10, 2025 | SAP_001.pdf |
Not provided
| 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 |
Not provided
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| Multiple |
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