Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT03770403
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718373', 'term': 'efgartigimod alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'regulatory@argenx.com', 'phone': '+32 93103400', 'title': 'Regulatory Manager', 'organization': 'argenx BVBA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years', 'description': 'The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \\>=1 dose or part of a dose of efgartigimod in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Efgartigimod', 'description': 'Participants were administered efgartigimod IV 10 mg/kg over 1 hour every 7 days for 4 administrations per TP for 3 weeks in this study irrespective of whether they received efgartigimod or placebo in ARGX-113-1704. After the fourth infusion, participants entered an ITP of variable duration (minimum 4 weeks between treatment periods). Subsequent TPs were implemented according to clinical response.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 83, 'seriousNumAtRisk': 145, 'deathsNumAffected': 5, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 103, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Defect conduction intraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Squamous cell carcinoma of the vulva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebral venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myasthenia gravis crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stupor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder neck obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonitis aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Shoulder arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in AChR-Positive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants were administered efgartigimod IV 10 mg/kg over 1 hour every 7 days for 4 administrations per TP for 3 weeks in this study irrespective of whether they received efgartigimod or placebo in ARGX-113-1704. After the fourth infusion, participants entered an ITP of variable duration (minimum 4 weeks between treatment periods). Subsequent TPs were implemented according to clinical response.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-emergent SAE', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Fatal TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years', 'description': "An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (electrocardiogram \\[ECG\\], radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. A serious AE (SAE) was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \\>=1 dose or part of a dose of efgartigimod in this study. Only those participants with AChR-positive status are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efgartigimod', 'description': 'Participants were administered efgartigimod IV 10 mg/kg over 1 hour every 7 days for 4 administrations per TP for 3 weeks in this study irrespective of whether they received efgartigimod or placebo in ARGX-113-1704. After the fourth infusion, participants entered an ITP of variable duration (minimum 4 weeks between treatment periods). Subsequent TPs were implemented according to clinical response.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-emergent SAE', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Fatal TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years', 'description': "Overall population included both AChR-Ab seropositive and AChR-Ab seronegative participants. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (ECG, radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. An SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \\>=1 dose or part of a dose of efgartigimod in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efgartigimod', 'description': 'Participants were administered efgartigimod intravenous (IV) 10 milligrams/kilograms (mg/kg) over 1 hour every 7 days for 4 administrations per treatment period (TP) for 3 weeks in this study irrespective of whether they received efgartigimod or placebo in ARGX-113-1704. After the fourth infusion, participants entered an intertreatment period (ITP) of variable duration (minimum 4 weeks between treatment periods). Subsequent TPs were implemented according to clinical response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}]}]}], 'recruitmentDetails': 'This Phase III, open-label study was a follow-on study of ARGX-113-1704 (NCT03669588) and was conducted in participants with myasthenia gravis having generalized muscle weakness at 51 investigational sites in 14 countries between 01 Mar 2019 and 30 Jun 2022. This study was conducted in 2 sequential parts: Part A (1 year) and Part B (\\<=2 years).', 'preAssignmentDetails': 'Participants from ARGX-113-1704 who either completed that study or required retreatment that could not be completed during a treatment cycle in that study were included in this study to receive efgartigimod. A total of 151 participants rolled over to this study and 145 of them received at least 1 dose of study treatment. Participants starting part B of this study were eligible to roll over in ARGX-113-2002 study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Efgartigimod', 'description': 'Participants were administered efgartigimod IV 10 mg/kg over 1 hour every 7 days for 4 administrations per TP for 3 weeks in this study irrespective of whether they received efgartigimod or placebo in ARGX-113-1704. After the fourth infusion, participants entered an ITP of variable duration (minimum 4 weeks between treatment periods). Subsequent TPs were implemented according to clinical response.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '14.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Anti-acetylcholine receptor antibodies (AChR-Ab) status', 'classes': [{'categories': [{'title': 'AChR-Ab seropositive', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': 'AChR-Ab seronegative', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis set consisted of all participants who rolled over from ARGX-113-1704 and received \\>=1 dose or part of a dose of efgartigimod in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-19', 'size': 3938141, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-21T11:42', 'hasProtocol': True}, {'date': '2022-09-20', 'size': 4484151, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-21T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04777734', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2018-11-16', 'resultsFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-21', 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in AChR-Positive Participants', 'timeFrame': 'TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years', 'description': "An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (electrocardiogram \\[ECG\\], radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. A serious AE (SAE) was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs, Treatment-Emergent SAEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in the Overall Population', 'timeFrame': 'TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years', 'description': "Overall population included both AChR-Ab seropositive and AChR-Ab seronegative participants. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (ECG, radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of participant's last visit were considered as TEAEs. An SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Myasthenia Gravis']}, 'referencesModule': {'references': [{'pmid': '38318236', 'type': 'DERIVED', 'citation': "Howard JF Jr, Bril V, Vu T, Karam C, Peric S, De Bleecker JL, Murai H, Meisel A, Beydoun SR, Pasnoor M, Guglietta A, Van Hoorick B, Steeland S, T'joen C, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT+ Study Group. Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis. Front Neurol. 2024 Jan 17;14:1284444. doi: 10.3389/fneur.2023.1284444. eCollection 2023."}, {'pmid': '34146511', 'type': 'DERIVED', 'citation': 'Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9.'}]}, 'descriptionModule': {'briefSummary': 'This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.\n\nOther more specific inclusion criteria are further defined in the protocol.\n\nExclusion Criteria:\n\n1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial.\n2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.\n3. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.\n4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity.\n\nOther, more specific exclusion criteria are further defined in the protocol.'}, 'identificationModule': {'nctId': 'NCT03770403', 'acronym': 'ADAPT+', 'briefTitle': 'A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness', 'orgStudyIdInfo': {'id': 'ARGX-113-1705'}, 'secondaryIdInfos': [{'id': '2018-002133-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARGX-113', 'interventionNames': ['Biological: ARGX-113']}], 'interventions': [{'name': 'ARGX-113', 'type': 'BIOLOGICAL', 'otherNames': ['efgartigimod'], 'description': 'Intravenous administration of ARGX-113', 'armGroupLabels': ['ARGX-113']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 42', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 8', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 33', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 21', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 41', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site 14', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigator Site 32', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site 18', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigator Site 12', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator Site 37', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Investigator Site 11', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigator Site 7', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigator Site 20', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Investigator Site 25', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Investigator Site 16', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '70852', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'Investigator Site 19'}, {'zip': '12800', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Investigator Site 30', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Investigator Site 49', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Investigator Site 17', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigator Site 50', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Investigator Site 51', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 45', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0114', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 31', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0114', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 46', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigator Site 28', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '1204', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigator Site 35', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Investigator Site 52', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Investigator Site 10', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Investigator Site 5', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00189', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigator Site 38', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '060-8543', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Investigator Site 24', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '025-0075', 'city': 'Hanamaki-shi', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Investigator Site 13'}, {'zip': '983-8520', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Investigator Site 27', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '589-8511', 'city': 'Ōsaka-sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Investigator Site 23', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Investigator Site 22', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '153-8515', 'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Investigator Site 40', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'zip': '160-0023', 'city': 'Shinjuku-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Investigator Site 43'}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Investigator Site 47', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '730-8518', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Investigator Site 44', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Minato', 'country': 'Japan', 'facility': 'Investigator Site 48', 'geoPoint': {'lat': 34.2152, 'lon': 135.1501}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Investigator Site 36', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Investigator Site 9', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '40-123', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Investigator Site 29', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-505', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigator Site 6', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Investigator Site 15', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '630087', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Investigator Site 34', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'Investigator Site 39', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Investigator Site 26', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Sabine Coppieters, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'argenx'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}