Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05291520
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs, all cause mortality and non-SAEs were collected from Day 1 post-administration up to Week 24.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Medical device site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days post-dose', 'description': 'ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'ALT, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'ALT, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7587', 'groupId': 'OG000', 'lowerLimit': '4789', 'upperLimit': '10380'}, {'value': '31560', 'groupId': 'OG001', 'lowerLimit': '27620', 'upperLimit': '35490'}, {'value': '12840', 'groupId': 'OG002', 'lowerLimit': '8883', 'upperLimit': '16800'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.', 'unitOfMeasure': 'Day*microgram/mililitre (day*μg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'AUC From Time Zero to Time t (AUC[0-t]) of VH3810109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6996', 'groupId': 'OG000', 'lowerLimit': '4512', 'upperLimit': '9479'}, {'value': '29160', 'groupId': 'OG001', 'lowerLimit': '25550', 'upperLimit': '32770'}, {'value': '11590', 'groupId': 'OG002', 'lowerLimit': '7819', 'upperLimit': '15360'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.', 'unitOfMeasure': 'day*μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of VH3810109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '148.2', 'groupId': 'OG000', 'lowerLimit': '117.3', 'upperLimit': '179.1'}, {'value': '1864', 'groupId': 'OG001', 'lowerLimit': '1620', 'upperLimit': '2107'}, {'value': '321.1', 'groupId': 'OG002', 'lowerLimit': '201.6', 'upperLimit': '440.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Concentration (Tmax) of VH3810109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.503', 'groupId': 'OG000', 'lowerLimit': '1.472', 'upperLimit': '7.535'}, {'value': '0.046', 'groupId': 'OG001', 'lowerLimit': '0.045', 'upperLimit': '0.047'}, {'value': '2.882', 'groupId': 'OG002', 'lowerLimit': '2.586', 'upperLimit': '3.178'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Phase Half-life (t1/2) of VH3810109', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.17', 'groupId': 'OG000', 'lowerLimit': '23.41', 'upperLimit': '52.93'}, {'value': '46.97', 'groupId': 'OG001', 'lowerLimit': '40.86', 'upperLimit': '53.09'}, {'value': '44.95', 'groupId': 'OG002', 'lowerLimit': '34.14', 'upperLimit': '55.76'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK Parameter Analysis Set, which included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Acceptance of ISRs, Day 2', 'categories': [{'measurements': [{'value': '1.44', 'spread': '1.050', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.496', 'groupId': 'OG001'}]}]}, {'title': 'Acceptance of ISRs, Day 7', 'categories': [{'measurements': [{'value': '1.44', 'spread': '0.729', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.802', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Not at all bothered by pain, Day 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'A little bothered by pain, Day 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderately bothered by pain, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very bothered by pain, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extremely bothered by pain, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not at all bothered by pain, Day 7', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'A little bothered by pain, Day 7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Moderately bothered by pain, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very bothered by pain, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extremely bothered by pain, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.\n\nScores range from 1 to 5; the scores are defined as following: 1=not at all bothered, 2=a little bothered, 3=moderately bothered, 4=very bothered, 5=extremely bothered; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Totally acceptable local reactions, Day 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Very acceptable local reactions, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderately acceptable local reactions, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'A little acceptable local reactions, Day 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not at all acceptable local reactions, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Totally acceptable local reactions, Day 7', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Very acceptable local reactions, Day 7', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderately acceptable local reactions, Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'A little acceptable local reactions, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not at all acceptable local reactions, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Totally acceptable pain, Day 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Very acceptable pain, Day 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Moderately acceptable pain, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'A little acceptable pain, Day 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not at all acceptable pain, Day 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Totally acceptable pain, Day 7', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Very acceptable pain, Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderately acceptable pain, Day 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'A little acceptable pain, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not at all acceptable pain, Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.\n\nScores range from 1 to 5; the scores are defind as following: 1=totaly acceptable, 2=very acceptable, 3=moderately acceptable, 4=a little acceptable, 5=not at all acceptable; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety Set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3.63', 'spread': '2.326', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '2.550', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '3.63', 'spread': '2.615', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.744', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '3.63', 'spread': '2.925', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.744', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 1, Day 2 and Day 7', 'description': 'Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.50', 'spread': '1.069', 'groupId': 'OG000'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.642', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.50', 'spread': '1.414', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 1, Day 2 and Day 7', 'description': 'Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Number of ISRs Events Overall and by Grade (Part 1 and 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'Number of events', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Overall ISRs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1 ISRs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2 ISRs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 ISRs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 ISRs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5 ISRs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to day 14', 'description': 'ISRs were recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity was categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated, Grade 5 (death). Higher grade indicates more severe condition.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of events', 'denomUnitsSelected': 'Number of events', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'The Overall Duration of ISRs, Expressed in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '6.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 up to Day 14', 'description': 'ISRs will be recorded via ISR diaries and managed through investigator assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Safety set which included all participants that received at least one dose of the study intervention and had data for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Basophils, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.0139', 'groupId': 'OG000'}, {'value': '0.035', 'spread': '0.0207', 'groupId': 'OG001'}, {'value': '0.044', 'spread': '0.0106', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0092', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0151', 'groupId': 'OG001'}, {'value': '-0.009', 'spread': '0.0083', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0152', 'groupId': 'OG001'}, {'value': '-0.009', 'spread': '0.0113', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0172', 'groupId': 'OG001'}, {'value': '-0.001', 'spread': '0.0181', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0128', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0128', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.0107', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0098', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0283', 'groupId': 'OG001'}]}]}, {'title': 'Basophils, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0064', 'groupId': 'OG000'}, {'value': '0.008', 'spread': '0.0139', 'groupId': 'OG001'}, {'value': '0.003', 'spread': '0.0149', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0139', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0141', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0185', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0083', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0192', 'groupId': 'OG001'}, {'value': '-0.001', 'spread': '0.0121', 'groupId': 'OG002'}]}]}, {'title': 'Basophils, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0151', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0259', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '0.0160', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.121', 'spread': '0.0957', 'groupId': 'OG000'}, {'value': '0.098', 'spread': '0.0333', 'groupId': 'OG001'}, {'value': '0.145', 'spread': '0.1370', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.0851', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.0151', 'groupId': 'OG001'}, {'value': '0.016', 'spread': '0.0385', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.0121', 'groupId': 'OG001'}, {'value': '0.010', 'spread': '0.0513', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.0194', 'groupId': 'OG001'}, {'value': '0.010', 'spread': '0.0431', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0964', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0293', 'groupId': 'OG001'}, {'value': '0.016', 'spread': '0.0619', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0320', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.0424', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.0718', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0624', 'groupId': 'OG001'}, {'value': '0.025', 'spread': '0.0444', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.0644', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0290', 'groupId': 'OG001'}, {'value': '-0.004', 'spread': '0.0403', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.1667', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.1269', 'groupId': 'OG001'}, {'value': '0.013', 'spread': '0.0605', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.1063', 'groupId': 'OG000'}, {'value': '0.094', 'spread': '0.1445', 'groupId': 'OG001'}, {'value': '-0.001', 'spread': '0.0527', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '1.161', 'groupId': 'OG000'}, {'value': '6.31', 'spread': '1.365', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '2.036', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.696', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.253', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.980', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.113', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '1.089', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '1.386', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '1.360', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.872', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.171', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '2.165', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.997', 'groupId': 'OG001'}]}]}, {'title': 'WBC, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'WBC, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.809', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.791', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.994', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.261', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.857', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '1.340', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.892', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '1.073', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '1.162', 'groupId': 'OG002'}]}]}, {'title': 'WBC, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.883', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '2.438', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.540', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.368', 'spread': '0.2680', 'groupId': 'OG000'}, {'value': '2.214', 'spread': '0.5545', 'groupId': 'OG001'}, {'value': '2.086', 'spread': '0.4824', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.1908', 'groupId': 'OG000'}, {'value': '-0.484', 'spread': '0.3503', 'groupId': 'OG001'}, {'value': '-0.094', 'spread': '0.2147', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.175', 'spread': '0.3459', 'groupId': 'OG001'}, {'value': '-0.135', 'spread': '0.2727', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.065', 'spread': '0.3551', 'groupId': 'OG001'}, {'value': '-0.106', 'spread': '0.3847', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.043', 'spread': '0.1763', 'groupId': 'OG000'}, {'value': '-0.211', 'spread': '0.3189', 'groupId': 'OG001'}, {'value': '-0.175', 'spread': '0.3166', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.193', 'spread': '0.3462', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.475', 'spread': '0.0778', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1664', 'groupId': 'OG000'}, {'value': '-0.386', 'spread': '0.3366', 'groupId': 'OG001'}, {'value': '-0.161', 'spread': '0.3561', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.063', 'spread': '0.1943', 'groupId': 'OG000'}, {'value': '-0.314', 'spread': '0.2911', 'groupId': 'OG001'}, {'value': '-0.226', 'spread': '0.2908', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.100', 'spread': '0.2441', 'groupId': 'OG000'}, {'value': '-0.190', 'spread': '0.2478', 'groupId': 'OG001'}, {'value': '-0.191', 'spread': '0.3559', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.3377', 'groupId': 'OG000'}, {'value': '-0.380', 'spread': '0.3497', 'groupId': 'OG001'}, {'value': '-0.339', 'spread': '0.4461', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.396', 'spread': '0.1556', 'groupId': 'OG000'}, {'value': '0.461', 'spread': '0.1038', 'groupId': 'OG001'}, {'value': '0.485', 'spread': '0.1488', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.1037', 'groupId': 'OG000'}, {'value': '-0.048', 'spread': '0.1159', 'groupId': 'OG001'}, {'value': '-0.008', 'spread': '0.0587', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': '0.0639', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '0.0886', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.080', 'spread': '0.0957', 'groupId': 'OG001'}, {'value': '-0.006', 'spread': '0.1034', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.1185', 'groupId': 'OG000'}, {'value': '-0.021', 'spread': '0.1572', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '0.1413', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.008', 'spread': '0.1019', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.110', 'spread': '0.1131', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.1347', 'groupId': 'OG000'}, {'value': '-0.078', 'spread': '0.1237', 'groupId': 'OG001'}, {'value': '-0.015', 'spread': '0.1319', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.1061', 'groupId': 'OG000'}, {'value': '-0.045', 'spread': '0.1146', 'groupId': 'OG001'}, {'value': '-0.034', 'spread': '0.1010', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, 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[{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.270', 'spread': '0.3111', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.340', 'spread': '0.7531', 'groupId': 'OG000'}, {'value': '0.096', 'spread': '0.8912', 'groupId': 'OG001'}, {'value': '-0.116', 'spread': '0.7571', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.160', 'spread': '1.2887', 'groupId': 'OG000'}, {'value': '-0.036', 'spread': '0.9269', 'groupId': 'OG001'}, {'value': '-0.233', 'spread': '1.1531', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.178', 'spread': '0.6481', 'groupId': 'OG000'}, {'value': '-0.468', 'spread': '0.9437', 'groupId': 'OG001'}, {'value': '-0.500', 'spread': '0.9401', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.535', 'spread': '0.8511', 'groupId': 'OG000'}, {'value': '0.691', 'spread': '2.3541', 'groupId': 'OG001'}, {'value': '-0.160', 'spread': '0.6340', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, 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[{'measurements': [{'value': '2.8', 'spread': '12.14', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '19.80', 'groupId': 'OG001'}]}]}, {'title': 'Platelets, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '32.89', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '52.60', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '40.86', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '87.1', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '15.10', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '31.31', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '19.34', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '35.49', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '31.43', 'groupId': 'OG002'}]}]}, {'title': 'Platelets, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '27.58', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '37.14', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '27.79', 'groupId': 'OG002'}]}]}], 'paramType': 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'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '6.79', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '5.39', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '7.19', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '5.46', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '5.28', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '4.37', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.84', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '5.90', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '4.47', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '6.55', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '4.96', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '8.01', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '4.12', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '7.54', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '13.99', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.0', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '43.9', 'spread': '3.44', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.73', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.40', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.58', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.00', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.43', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.16', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '2.48', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '4.40', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '4.17', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3.51', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.93', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '3.04', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '2.20', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '3.52', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.76', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '2.71', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.38', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '3.14', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '3.85', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '3.87', 'groupId': 'OG002'}]}]}, {'title': 'Total Protein, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '4.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.', 'unitOfMeasure': 'Grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Blood Cell Count (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.518', 'spread': '0.5518', 'groupId': 'OG000'}, {'value': '4.523', 'spread': '0.4014', 'groupId': 'OG001'}, {'value': '4.889', 'spread': '0.6362', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.180', 'spread': '0.2654', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.1717', 'groupId': 'OG001'}, {'value': '0.141', 'spread': '0.2154', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.163', 'spread': '0.3064', 'groupId': 'OG001'}, {'value': '0.079', 'spread': '0.1890', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.085', 'spread': '0.2239', 'groupId': 'OG001'}, {'value': '0.056', 'spread': '0.2169', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.155', 'spread': '0.2067', 'groupId': 'OG000'}, {'value': '0.084', 'spread': '0.1584', 'groupId': 'OG001'}, {'value': '-0.074', 'spread': '0.1429', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.1877', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.315', 'spread': '0.1626', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.130', 'spread': '0.1646', 'groupId': 'OG000'}, {'value': '-0.088', 'spread': '0.1940', 'groupId': 'OG001'}, {'value': '-0.064', 'spread': '0.1686', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.1802', 'groupId': 'OG000'}, {'value': '-0.026', 'spread': '0.1625', 'groupId': 'OG001'}, {'value': '-0.078', 'spread': '0.1814', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.2612', 'groupId': 'OG000'}, {'value': '0.124', 'spread': '0.2212', 'groupId': 'OG001'}, {'value': '-0.164', 'spread': '0.0752', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.063', 'spread': '0.1496', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.2326', 'groupId': 'OG001'}, {'value': '-0.110', 'spread': '0.3089', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.', 'unitOfMeasure': 'Trillion cells/L (TI/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Corpuscle Volume (MCV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with 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[{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.466', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.478', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.354', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.492', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.345', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.38', 'spread': '0.542', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.589', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.661', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.562', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.469', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.674', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.354', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.784', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.746', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.623', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '1.216', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '1.125', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.703', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.842', 'groupId': 'OG000'}, {'value': 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'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000000', 'spread': '0.1570060', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.027755', 'spread': '0.2586688', 'groupId': 'OG000'}, {'value': '0.048571', 'spread': '0.3884992', 'groupId': 'OG001'}, {'value': '0.006939', 'spread': '0.2790329', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.027755', 'spread': '0.3857275', 'groupId': 'OG000'}, {'value': '-0.124898', 'spread': '0.2842106', 'groupId': 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'groupId': 'OG002'}]}]}, {'title': 'Blood urea nitrogen, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31684', 'spread': '0.895135', 'groupId': 'OG000'}, {'value': '-0.16065', 'spread': '0.695659', 'groupId': 'OG001'}, {'value': '-0.24098', 'spread': '1.082288', 'groupId': 'OG002'}]}]}, {'title': 'Blood urea nitrogen, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.21420', 'spread': '1.260309', 'groupId': 'OG000'}, {'value': '-0.41948', 'spread': '0.805711', 'groupId': 'OG001'}, {'value': '0.03060', 'spread': '1.359639', 'groupId': 'OG002'}]}]}, {'title': 'Blood urea nitrogen, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 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'spread': '8.05969', 'groupId': 'OG000'}, {'value': '-3.2045', 'spread': '3.97975', 'groupId': 'OG001'}, {'value': '2.3205', 'spread': '9.02667', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7367', 'spread': '6.16058', 'groupId': 'OG001'}, {'value': '3.6465', 'spread': '5.49905', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5893', 'spread': '6.03887', 'groupId': 'OG001'}, {'value': '0.8840', 'spread': '7.94898', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '5.84472', 'groupId': 'OG000'}, {'value': '2.4310', 'spread': '6.71158', 'groupId': 'OG001'}, {'value': '6.2985', 'spread': '9.30077', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4420', 'spread': '6.01510', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.9340', 'spread': '3.12541', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 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'groupId': 'OG000'}, {'value': '-0.7735', 'spread': '7.98314', 'groupId': 'OG001'}, {'value': '3.1571', 'spread': '5.32501', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0995', 'spread': '4.25102', 'groupId': 'OG000'}, {'value': '-0.2210', 'spread': '5.62574', 'groupId': 'OG001'}, {'value': '5.6829', 'spread': '7.60201', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0306', 'spread': '0.49592', 'groupId': 'OG000'}, {'value': '1.7741', 'spread': '0.62621', 'groupId': 'OG001'}, {'value': '2.1161', 'spread': '1.04191', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5771', 'spread': '0.42811', 'groupId': 'OG000'}, {'value': '-0.2138', 'spread': '0.45473', 'groupId': 'OG001'}, {'value': '-0.0214', 'spread': '0.44250', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1425', 'spread': '0.45134', 'groupId': 'OG001'}, {'value': '-0.1069', 'spread': '0.43776', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0285', 'spread': '0.47656', 'groupId': 'OG001'}, {'value': '0.1283', 'spread': '0.58348', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.43836', 'groupId': 'OG000'}, {'value': '0.0214', 'spread': '0.42320', 'groupId': 'OG001'}, {'value': '-0.1283', 'spread': '0.33893', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1995', 'spread': '0.53440', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5130', 'spread': '0.48366', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2351', 'spread': '0.57763', 'groupId': 'OG000'}, {'value': '-0.3634', 'spread': '0.46997', 'groupId': 'OG001'}, {'value': '-0.1710', 'spread': '0.44778', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5344', 'spread': '0.62287', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.42872', 'groupId': 'OG001'}, {'value': '-0.1496', 'spread': '0.50427', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3206', 'spread': '0.59544', 'groupId': 'OG000'}, {'value': '-0.2138', 'spread': '0.52308', 'groupId': 'OG001'}, {'value': '-0.7817', 'spread': '0.56591', 'groupId': 'OG002'}]}]}, {'title': 'Direct Bilirubin, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3420', 'spread': '0.49222', 'groupId': 'OG000'}, {'value': '-0.2565', 'spread': '0.61993', 'groupId': 'OG001'}, {'value': '-0.3176', 'spread': '0.36178', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.7684', 'spread': '3.95623', 'groupId': 'OG000'}, {'value': '10.4738', 'spread': '3.28512', 'groupId': 'OG001'}, {'value': '12.5258', 'spread': '7.47987', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.9879', 'spread': '2.22382', 'groupId': 'OG000'}, {'value': '-1.1115', 'spread': '3.08613', 'groupId': 'OG001'}, {'value': '0.6413', 'spread': '2.98813', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8550', 'spread': '2.99128', 'groupId': 'OG001'}, {'value': '0.4061', 'spread': '3.48526', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0570', 'spread': '2.84018', 'groupId': 'OG001'}, {'value': '2.0306', 'spread': '4.64850', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6031', 'spread': '2.82603', 'groupId': 'OG000'}, {'value': '-0.2565', 'spread': '3.16102', 'groupId': 'OG001'}, {'value': '-0.4703', 'spread': '2.08181', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9405', 'spread': '3.54057', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.3085', 'spread': '1.81373', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6199', 'spread': '3.02728', 'groupId': 'OG000'}, {'value': '-2.4368', 'spread': '2.07377', 'groupId': 'OG001'}, {'value': '-0.6199', 'spread': '3.52222', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7528', 'spread': '3.77392', 'groupId': 'OG000'}, {'value': '-1.1115', 'spread': '1.51851', 'groupId': 'OG001'}, {'value': '-0.3206', 'spread': '3.67145', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4061', 'spread': '3.45758', 'groupId': 'OG000'}, {'value': '-1.5390', 'spread': '2.90772', 'groupId': 'OG001'}, {'value': '-2.4917', 'spread': '2.46196', 'groupId': 'OG002'}]}]}, {'title': 'Total bilirubin, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0428', 'spread': '2.98813', 'groupId': 'OG000'}, {'value': '-0.6840', 'spread': '3.10368', 'groupId': 'OG001'}, {'value': '-1.6856', 'spread': '2.63700', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Calcium, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.329706', 'spread': '0.1049575', 'groupId': 'OG000'}, {'value': '2.317231', 'spread': '0.0805028', 'groupId': 'OG001'}, {'value': '2.351538', 'spread': '0.0931159', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.015594', 'spread': '0.1041067', 'groupId': 'OG000'}, {'value': '-0.003119', 'spread': '0.0983979', 'groupId': 'OG001'}, {'value': '-0.003119', 'spread': '0.0983979', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.037425', 'spread': '0.1101762', 'groupId': 'OG001'}, {'value': '0.003119', 'spread': '0.0759557', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.008317', 'spread': '0.1145166', 'groupId': 'OG001'}, {'value': '0.040544', 'spread': '0.0729700', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.012475', 'spread': '0.0533453', 'groupId': 'OG000'}, {'value': '-0.006238', 'spread': '0.0830180', 'groupId': 'OG001'}, {'value': '0.037425', 'spread': '0.0442316', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.004158', 'spread': '0.0639356', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.112275', 'spread': '0.0882116', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.009356', 'spread': '0.0398698', 'groupId': 'OG000'}, {'value': '-0.034306', 'spread': '0.0923367', 'groupId': 'OG001'}, {'value': '-0.009356', 'spread': '0.0923367', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.031188', 'spread': '0.0739536', 'groupId': 'OG000'}, {'value': '-0.034306', 'spread': '0.0853291', 'groupId': 'OG001'}, {'value': '0.003119', 'spread': '0.0826826', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.015594', 'spread': '0.0842805', 'groupId': 'OG000'}, {'value': '0.018713', 'spread': '0.0751464', 'groupId': 'OG001'}, {'value': '-0.064157', 'spread': '0.0496021', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.056138', 'spread': '0.0861717', 'groupId': 'OG000'}, {'value': '-0.031188', 'spread': '0.0371268', 'groupId': 'OG001'}, {'value': '-0.053464', 'spread': '0.1002445', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '1.92', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.71', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Carbon Dioxide, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '1.41', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '103.1', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '102.4', 'spread': '2.20', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '2.42', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.49', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '2.39', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '2.14', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Chloride, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.13', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.06', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.80', 'groupId': 'OG002'}]}]}, {'title': 'Chloride, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.21', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.36', 'spread': '0.484', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '0.342', 'groupId': 'OG001'}, {'value': '4.29', 'spread': '0.485', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.325', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.366', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.372', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.250', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.544', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.320', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.421', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.470', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.340', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.207', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.354', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.381', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.513', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.458', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.389', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.183', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.196', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.413', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.189', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.382', 'groupId': 'OG002'}]}]}, {'title': 'Potassium, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.308', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.8', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '137.1', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '136.9', 'spread': '2.53', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '2.30', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.49', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.98', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.85', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.64', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.60', 'groupId': 'OG002'}]}]}, {'title': 'Sodium, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.48', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.', 'unitOfMeasure': 'Millimole per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'ALT, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '8.09', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '3.45', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '4.61', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.43', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '6.14', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.73', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '7.91', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '3.76', 'groupId': 'OG001'}]}]}, {'title': 'ALT, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'ALT, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '5.81', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '8.18', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.45', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '7.06', 'groupId': 'OG002'}]}]}, {'title': 'ALT, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '5.70', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '5.96', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '2.64', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '3.06', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '3.42', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '3.66', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.74', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '3.03', 'groupId': 'OG001'}]}]}, {'title': 'AST, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'AST, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '3.40', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '8.96', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '4.38', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '3.14', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '3.95', 'groupId': 'OG002'}]}]}, {'title': 'AST, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '2.63', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '20.00', 'groupId': 'OG001'}, {'value': '57.1', 'spread': '9.30', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '4.50', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '4.44', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '4.81', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '5.83', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '3.89', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '5.33', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '5.04', 'groupId': 'OG001'}]}]}, {'title': 'ALP, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'ALP, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '4.17', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '4.71', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '4.52', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '2.76', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '5.42', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '5.39', 'groupId': 'OG002'}]}]}, {'title': 'ALP, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '5.85', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '4.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.', 'unitOfMeasure': 'International Units per liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Glucose', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Protein', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocyte esterase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14 compared with baseline (Day -1)', 'description': 'Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'PR Interval, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '161.375', 'spread': '20.2762', 'groupId': 'OG000'}, {'value': '164.000', 'spread': '16.6733', 'groupId': 'OG001'}, {'value': '164.875', 'spread': '14.2872', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.000', 'spread': '10.7157', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '4.5145', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.208', 'spread': '7.5297', 'groupId': 'OG000'}, {'value': '1.917', 'spread': '9.5282', 'groupId': 'OG001'}, {'value': '3.500', 'spread': '7.6677', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.083', 'spread': '7.8493', 'groupId': 'OG000'}, {'value': '3.000', 'spread': '10.6354', 'groupId': 'OG001'}, {'value': '3.667', 'spread': '10.6845', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.625', 'spread': '8.6179', 'groupId': 'OG000'}, {'value': '0.875', 'spread': '10.8656', 'groupId': 'OG001'}, {'value': '3.000', 'spread': '10.0775', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.458', 'spread': '11.6223', 'groupId': 'OG000'}, {'value': '6.167', 'spread': '10.9516', 'groupId': 'OG001'}, {'value': '2.625', 'spread': '6.3507', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.875', 'spread': '9.4330', 'groupId': 'OG001'}]}]}, {'title': 'PR Interval, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.167', 'spread': '8.7210', 'groupId': 'OG001'}]}]}, {'title': 'PR Interval, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.542', 'spread': '5.9038', 'groupId': 'OG000'}, {'value': '4.250', 'spread': '11.7700', 'groupId': 'OG001'}, {'value': '-2.250', 'spread': '10.6231', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.583', 'spread': '10.1164', 'groupId': 'OG000'}, {'value': '-0.958', 'spread': '11.6571', 'groupId': 'OG001'}, {'value': '-1.905', 'spread': '12.0872', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.875', 'spread': '8.1141', 'groupId': 'OG000'}, {'value': '90.750', 'spread': '11.8291', 'groupId': 'OG001'}, {'value': '100.250', 'spread': '12.1155', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.875', 'spread': '3.5587', 'groupId': 'OG000'}, {'value': '-5.250', 'spread': '6.8098', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.292', 'spread': '2.6693', 'groupId': 'OG000'}, {'value': '-0.458', 'spread': '3.7116', 'groupId': 'OG001'}, {'value': '-3.708', 'spread': '5.6833', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.875', 'spread': '2.3363', 'groupId': 'OG000'}, {'value': '-2.833', 'spread': '6.2463', 'groupId': 'OG001'}, {'value': '-2.583', 'spread': '3.6764', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.458', 'spread': '5.0895', 'groupId': 'OG000'}, {'value': '-1.875', 'spread': '6.0708', 'groupId': 'OG001'}, {'value': '-4.458', 'spread': '6.4855', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '5.1052', 'groupId': 'OG000'}, {'value': '-1.500', 'spread': '6.8359', 'groupId': 'OG001'}, {'value': '-2.917', 'spread': '6.3164', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.042', 'spread': '4.6987', 'groupId': 'OG001'}]}]}, {'title': 'QRS Interval, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.333', 'spread': '6.5997', 'groupId': 'OG001'}]}]}, {'title': 'QRS Interval, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.708', 'spread': '3.9337', 'groupId': 'OG000'}, {'value': '-0.958', 'spread': '3.8398', 'groupId': 'OG001'}, {'value': '-4.708', 'spread': '6.2372', 'groupId': 'OG002'}]}]}, {'title': 'QRS Interval, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.917', 'spread': '4.5066', 'groupId': 'OG000'}, {'value': '-0.458', 'spread': '4.4755', 'groupId': 'OG001'}, {'value': '-5.238', 'spread': '6.4599', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '378.875', 'spread': '17.7719', 'groupId': 'OG000'}, {'value': '395.875', 'spread': '19.1493', 'groupId': 'OG001'}, {'value': '380.375', 'spread': '12.3513', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.708', 'spread': '12.1713', 'groupId': 'OG000'}, {'value': '-0.625', 'spread': '8.6620', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.750', 'spread': '12.1299', 'groupId': 'OG000'}, {'value': '20.750', 'spread': '18.9684', 'groupId': 'OG001'}, {'value': '16.083', 'spread': '13.6449', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.583', 'spread': '18.2650', 'groupId': 'OG000'}, {'value': '10.542', 'spread': '27.0566', 'groupId': 'OG001'}, {'value': '9.792', 'spread': '12.7179', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.917', 'spread': '22.1616', 'groupId': 'OG000'}, {'value': '7.000', 'spread': '27.0725', 'groupId': 'OG001'}, {'value': '9.167', 'spread': '18.5267', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.042', 'spread': '20.7972', 'groupId': 'OG000'}, {'value': '21.083', 'spread': '21.4755', 'groupId': 'OG001'}, {'value': '8.500', 'spread': '13.6498', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.167', 'spread': '20.0206', 'groupId': 'OG001'}]}]}, {'title': 'QT Interval, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.667', 'spread': '55.1543', 'groupId': 'OG001'}]}]}, {'title': 'QT Interval, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.083', 'spread': '18.0614', 'groupId': 'OG000'}, {'value': '31.167', 'spread': '17.0023', 'groupId': 'OG001'}, {'value': '10.583', 'spread': '13.7318', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.125', 'spread': '21.3348', 'groupId': 'OG000'}, {'value': '13.167', 'spread': '21.5318', 'groupId': 'OG001'}, {'value': '15.952', 'spread': '10.9771', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '402.750', 'spread': '10.5119', 'groupId': 'OG000'}, {'value': '419.375', 'spread': '13.7523', 'groupId': 'OG001'}, {'value': '397.000', 'spread': '14.8131', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.833', 'spread': '10.0570', 'groupId': 'OG000'}, {'value': '1.375', 'spread': '9.1780', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.875', 'spread': '9.2923', 'groupId': 'OG000'}, {'value': '1.083', 'spread': '15.4486', 'groupId': 'OG001'}, {'value': '3.375', 'spread': '11.7924', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.917', 'spread': '9.5232', 'groupId': 'OG000'}, {'value': '-1.250', 'spread': '14.9047', 'groupId': 'OG001'}, {'value': '2.083', 'spread': '8.6295', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.000', 'spread': '15.0449', 'groupId': 'OG000'}, {'value': '-4.292', 'spread': '18.3220', 'groupId': 'OG001'}, {'value': '1.917', 'spread': '9.0847', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.667', 'spread': '22.8341', 'groupId': 'OG000'}, {'value': '0.958', 'spread': '9.6715', 'groupId': 'OG001'}, {'value': '3.500', 'spread': '11.9004', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.833', 'spread': '14.8410', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.667', 'spread': '33.9411', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.167', 'spread': '10.6398', 'groupId': 'OG000'}, {'value': '6.500', 'spread': '8.8515', 'groupId': 'OG001'}, {'value': '2.250', 'spread': '8.4867', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.417', 'spread': '10.5991', 'groupId': 'OG000'}, {'value': '2.229', 'spread': '14.8754', 'groupId': 'OG001'}, {'value': '7.238', 'spread': '5.6461', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'ECG values were collected as assessed by protocol, at the indicated time points.', 'unitOfMeasure': 'Miliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.54', 'spread': '0.233', 'groupId': 'OG000'}, {'value': '36.79', 'spread': '0.344', 'groupId': 'OG001'}, {'value': '36.49', 'spread': '0.500', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.437', 'groupId': 'OG001'}, {'value': '-0.14', 'spread': '0.342', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.475', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.454', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.311', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.569', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.463', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.524', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.622', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.578', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.599', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.566', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.392', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.492', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.453', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.554', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.352', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.469', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.364', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.534', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.549', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.399', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.535', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.566', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.607', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.423', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.575', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '0.534', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.315', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.414', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.505', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.364', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.678', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.367', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.', 'unitOfMeasure': 'Degrees Celcius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '7.16', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '12.26', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '8.28', 'groupId': 'OG001'}, {'value': '-13.8', 'spread': '10.66', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.6', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '9.01', 'groupId': 'OG001'}, {'value': '-12.1', 'spread': '8.63', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '8.75', 'groupId': 'OG001'}, {'value': '-8.1', 'spread': '11.52', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '18.68', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '6.95', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '14.81', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '7.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '6.72', 'groupId': 'OG001'}, {'value': '-11.4', 'spread': '16.95', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '11.43', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '5.06', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '18.45', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '7.34', 'groupId': 'OG001'}, {'value': '-13.4', 'spread': '12.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '15.13', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '8.09', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '15.75', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '7.44', 'groupId': 'OG001'}, {'value': '-9.8', 'spread': '14.21', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.1', 'spread': '10.25', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '8.61', 'groupId': 'OG001'}, {'value': '-10.6', 'spread': '10.66', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '5.01', 'groupId': 'OG001'}, {'value': '-12.4', 'spread': '8.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '4.80', 'groupId': 'OG001'}, {'value': '-15.3', 'spread': '11.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.', 'unitOfMeasure': 'Beats per minute (Beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '3.77', 'groupId': 'OG001'}, {'value': '13.8', 'spread': '1.98', 'groupId': 'OG002'}]}]}, {'title': 'Day 1/4 Hours Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '3.38', 'groupId': 'OG002'}]}]}, {'title': 'Day 1/8 Hours Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '3.85', 'groupId': 'OG002'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.85', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '2.71', 'groupId': 'OG002'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '2.62', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '4.89', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.92', 'groupId': 'OG002'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.38', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '3.85', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '4.41', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.59', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.83', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '3.34', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.33', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.42', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.95', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '3.98', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.', 'unitOfMeasure': 'Breaths per minute (Breaths/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assessed timepoints and analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'OG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'classes': [{'title': 'Systolic Blood Pressure, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '112.8', 'spread': '12.67', 'groupId': 'OG000'}, {'value': '106.3', 'spread': '11.68', 'groupId': 'OG001'}, {'value': '114.4', 'spread': '9.50', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '12.24', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '8.04', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '7.19', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '5.99', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '4.66', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '6.45', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '6.23', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '8.18', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '6.03', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '8.28', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '8.47', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '13.44', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '10.38', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '10.21', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '13.36', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '11.50', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '11.80', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '7.85', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '17.02', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '14.43', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '7.58', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '16.38', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '10.27', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '14.28', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '10.83', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '7.83', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '10.07', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '4.91', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.5', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '6.45', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '5.59', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '8.23', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '6.89', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '7.24', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '5.51', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '6.05', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.62', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '4.86', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.41', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '9.78', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '8.49', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '5.33', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '8.37', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '4.67', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '6.32', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '7.74', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '3.29', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '7.15', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '7.78', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '5.11', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '6.73', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '5.55', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '6.19', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '7.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK set, who included participants who received study intervention and for whom valid and evaluable serum PK parameters were derived for the assesses timepoints and analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'FG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'FG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'BG001', 'title': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.'}, {'id': 'BG002', 'title': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '7.76', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '14.45', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '10.59', 'groupId': 'BG002'}, {'value': '40.87', 'spread': '10.85', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-26', 'size': 2664206, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-09T02:59', 'hasProtocol': True}, {'date': '2022-08-15', 'size': 1654035, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-09T02:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This will be an open-label study. Hence, there will be no masking.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2022-02-16', 'resultsFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-09', 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)', 'timeFrame': 'Up to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) Following SC Administration of VH3810109 (Part 1 and Part 3)', 'timeFrame': 'Up to Week 24', 'description': 'An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.'}, {'measure': 'Number of Participants With Injection Site Reactions (ISRs) Following VH3810109 SC Administration (Part 1 and 3)', 'timeFrame': 'Up to 7 days post-dose', 'description': 'ISRs were recorded via ISR diaries and managed through investigator assessment. The participants who experienced any injection site reaction were reported.'}, {'measure': 'Number of Participants With Grade 2 to 4 Elevated Alanin Aminotransferase/Aspartate Aminotransferase (ALT/AST) Values Following VH3810109 SC Administration (Part 1 and 3)', 'timeFrame': 'Up to Week 24', 'description': 'Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.'}, {'measure': 'Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)', 'timeFrame': 'Up to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. This outcome measure is presenting only data for Grade 2 or more of severity.'}, {'measure': 'Number of Participants With SAEs Following IV Administration of VH3810109 (Part 2)', 'timeFrame': 'Up to Week 24', 'description': 'An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or other situations as judged by physician.'}, {'measure': 'Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)', 'timeFrame': 'Up to Week 24', 'description': 'Liver chemistry stopping and increased monitoring criteria is analyzed using DAIDS AE Grading Table, where Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis of VH3810109.'}, {'measure': 'AUC From Time Zero to Time t (AUC[0-t]) of VH3810109', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.'}, {'measure': 'Maximum Observed Concentration (Cmax) of VH3810109', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.'}, {'measure': 'Time of Maximum Observed Concentration (Tmax) of VH3810109', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.'}, {'measure': 'Apparent Terminal Phase Half-life (t1/2) of VH3810109', 'timeFrame': 'Up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for PK analysis of VH3810109.'}, {'measure': 'Score Recorded for "Acceptance of ISRs", Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.'}, {'measure': 'Number of Participants Reporting Pain, Using Perception of Injection (PIN) Questionnaire (Part 1 and 3)', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.\n\nScores range from 1 to 5; the scores are defined as following: 1=not at all bothered, 2=a little bothered, 3=moderately bothered, 4=very bothered, 5=extremely bothered; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.'}, {'measure': 'Number of Participants Reporting Being Bothered or Affected by the Pain and Local Reactions Based on the PIN Questionaire (Part 1 and 3)', 'timeFrame': 'At Day 2 and Day 7', 'description': 'The PIN questionnaire measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial.\n\nScores range from 1 to 5; the scores are defind as following: 1=totaly acceptable, 2=very acceptable, 3=moderately acceptable, 4=a little acceptable, 5=not at all acceptable; questions are phrased to ensure that 1: most favorable perception of vaccination, and 5: most unfavorable. Score of a dimension is calculated as mean of all items with dimension. Higher scores represent worse perception of injection.'}, {'measure': 'Score Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 SC Administration (Part 1 and 3)', 'timeFrame': 'At Day 1, Day 2 and Day 7', 'description': 'Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Scores Reported for Post-injection Pain Assessment Using Numeric Rating Scale (NRS) Following VH3810109 IV Administration (Part 2)', 'timeFrame': 'At Day 1, Day 2 and Day 7', 'description': 'Post-injection assessment of pain was measured based on NRS which is a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Number of ISRs Events Overall and by Grade (Part 1 and 3)', 'timeFrame': 'Up to day 14', 'description': 'ISRs were recorded via ISR diaries and managed through investigator assessment. Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity was categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated, Grade 5 (death). Higher grade indicates more severe condition.'}, {'measure': 'The Overall Duration of ISRs, Expressed in Days', 'timeFrame': 'From Day 1 up to Day 14', 'description': 'ISRs will be recorded via ISR diaries and managed through investigator assessment.'}, {'measure': 'Change From Baseline in Platelets, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Hematocrit', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Hemoglobin, Albumin and Total Protein', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Red Blood Cell Count (RBC)', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Mean Corpuscle Volume (MCV)', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Mean Corpuscle Hemoglobin (MCH)', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Change From Baseline in ALT, AST and Alkaline Phosphatase (ALP)', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109.'}, {'measure': 'Number of Participants With Worst Case Urinalysis at Post-baseline Compared With Baseline', 'timeFrame': 'Day 14 compared with baseline (Day -1)', 'description': 'Urine samples were collected as assessed by protocol, at specific time points for laboratory analysis of VH3810109. At baseline and post-baseline, worst case urinalysis data was determined by comparing the resulted values of the urinalysis for each participant to the normal rage. This endpoint evaluates the changes from baseline for the worst case urinalysis.'}, {'measure': "Change From Baseline in PR Interval, QRS Interval, QT Interval, and QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)", 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'ECG values were collected as assessed by protocol, at the indicated time points.'}, {'measure': 'Change From Baseline in Temperature', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Temperature was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.'}, {'measure': 'Change From Baseline in Pulse Rate', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Pulse rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.'}, {'measure': 'Change From Baseline in Respiratory Rate', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Respiratory rate was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'From Baseline (Day -1) up to Week 24', 'description': 'Blood pressure was measured at the indicated time points, in a supine position after the participant has been at rest for at least 5 minutes in a quiet setting without distractions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VH3810109', 'GSK3810109', 'HIV', 'Human Monoclonal Antibody', 'rHuPH20', 'Pharmacokinetics', 'Safety', 'Tolerability', 'N6LS'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '40698814', 'type': 'DERIVED', 'citation': "Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23."}]}, 'descriptionModule': {'briefSummary': 'An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and without history of any of the conditions listed in the exclusion criteria.\n* Participants having body weight of ≥50 kilogram (kg) and \\<100 kg\n* Participants having a clinical laboratory profile within the normal range or must have results that do not show clinically significant abnormalities, as judged by the investigator at screening.\n* Contraceptive use by men or women participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nParticipants who are female at birth are eligible to participate if at least one of the following conditions applies:\n\nNot pregnant or breastfeeding and at least one of the following conditions applies:\n\nIs not a participant of childbearing potential (POCBP) or Is a POCBP and agree to use an acceptable contraceptive method as described in Section 10.4 from 3 weeks prior to the start of this study and during the study. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n\nA POCBP must have a negative highly sensitive serum pregnancy test on Day -1, prior to the first dose of study intervention All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom).\n\nThe investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\n* Capable of giving written informed consent.\n\nExclusion Criteria:\n\n* Hypertension that is not well controlled.\n* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n* Positive human immunodeficiency virus (HIV) antibody test.\n* Positive test result for SARS-CoV-2.\n* Evidence of hepatitis B (HB) virus infection at screening or within 3 months prior to first dose of study intervention Participants positive for Hepatitis B antigen (HBsAg) are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for Hepatitis B virus (HBV) DNA are excluded\n* Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.\n* The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or tattoos that would interfere with assessment of injection sites.\n* History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.\n* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A, dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n* Exposure to an experimental drug, human blood product, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment OR plans to receive live vaccines during the study.\n* Prior receipt of licensed or investigational Monoclonal antibody (Mab).\n* Receipt of any investigational study agent within 28 days prior to first dose of study treatment\n* Prior exposure to VH3810109 or rHuPH20 in this or another clinical study.\n* Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.\n* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n* ALT ≥1.5 times the upper limit of normal (ULN).\n* Total bilirubin ≥1.5 times the ULN (isolated total bilirubin \\>1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin \\<35%).\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n* Corrected QT interval Fridericia's formula (QTcF)\\>450 millisecond (msec) for males and QTcF \\>470 msec for females.\n* The participant has a tattoo or other dermatological condition overlying potential injection sites that may interfere with interpretation of ISRs or administration of VH3810109.\n* Grade 4 laboratory abnormalities.\n* Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.\n* Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZ Drug Product (EDP)"}, 'identificationModule': {'nctId': 'NCT05291520', 'acronym': 'SPAN', 'briefTitle': 'A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults', 'orgStudyIdInfo': {'id': '217901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.', 'interventionNames': ['Biological: VH3810109', 'Biological: rHuPH20']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'description': 'Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.', 'interventionNames': ['Biological: VH3810109']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]', 'description': 'Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.', 'interventionNames': ['Biological: VH3810109', 'Biological: rHuPH20']}], 'interventions': [{'name': 'VH3810109', 'type': 'BIOLOGICAL', 'description': 'VH3810109 was administered.', 'armGroupLabels': ['Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'Part 2 Group: VH3810109 60 mg/kg [IV]', 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]']}, {'name': 'rHuPH20', 'type': 'BIOLOGICAL', 'description': 'rHuPH20 was administered.', 'armGroupLabels': ['Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]', 'Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}