Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT05305651
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711967', 'term': 'sotrovimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, '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': 'Up to Day 28', 'description': 'All-cause mortality, Treatment-emergent serious adverse events (TESAEs) and Treatment-emergent non-SAEs were reported for the Safety Set (Safety Set included all participants who were enrolled and exposed to study intervention).', 'eventGroups': [{'id': 'EG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 6, 'seriousNumAtRisk': 217, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Anosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by Next generation sequencing (NGS) analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the amino acid (AA) sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 14', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 14', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'AA substitutions >5% allelic frequency', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'AA substitutions >50% allelic frequency', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'SARS-CoV-2 VOC is defined by World health Organization(WHO) that meets definition of VUI and through a comparative assessment, has been demonstrated to be associated with 1 or more of following changes at degree of global public health(GPH) significance: increase in transmissibility or detrimental change in COVID-19 epidemiology, OR increase in virulence or change in clinical disease presentation, OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics. SARS-CoV-2 VUI is defined by WHO as a variant:with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune, diagnostic or therapeutic escape and identified to cause significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest emerging risk to GPH.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Number of participants with any VOC/VUI based on WHO classification and Pango sub-lineage for the earliest possible VOC/VUI sample has been presented.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7, Day 14, and Day 28', 'description': 'The number of participants that had undetectable viral load in nasal/oropharyngeal swabs was determined by quantitative reverse transcription-polymerase chain reaction (qRT/PCR) at Day 7, Day 14, and Day 28. Participants with major protocol deviation (out of visit window/samples received late/return more samples than expected) at specific visits were excluded from analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Safety Set included all participants who were enrolled and exposed to study intervention, and represents the Overall Number of Participants Analyzed field (i.e., contributed data reported in the table). 'Number Analyzed' signifies participants evaluable for the specified time points."}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Cause Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized due to any cause have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COVID-19 Related Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized due to COVID-19 have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring New or Increased Oxygen Support (Supplemental Oxygen [Not High Flow]), Non-invasive Ventilation or High-flow, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'New or increased oxygen support (supplemental oxygen [not high flow])', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Non-invasive ventilation or high flow', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Invasive mechanical ventilation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ECMO', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants required new or increased oxygen support (supplemental oxygen \\[not high flow\\]), non-invasive ventilation or high-flow, invasive mechanical ventilation or ECMO have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized in ICU due to any cause have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COVID-19 Related ICU Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized in ICU due to COVID-19 have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Due to Any Cause Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Data for number of participants who died due to any cause through Day 28 have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Due to COVID-19 Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Data for number of participants who died due to COVID-19 have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all participants who were enrolled and exposed to study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'Day 7, L5-L5F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L5-L5F Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P39-P39L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G75-G75C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G75-G75V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, T95-T95I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F106-F106 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Y144-Y144 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, H146-H146Q Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, V320-V320A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P330-P330S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G339-G339R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G339-G339Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, K356-K356M', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, K356-K356R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, K356-K356T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, S373-S373P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q474-Q474 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q493-Q493K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G496-G496V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, V503-V503F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L517-L517F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L517-L517P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, T523-T523I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F543-F543L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, T547-T547K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, K558-K558 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A570-A570T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, T572-T572I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P579-P579L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L585-L585F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, C590-C590Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F592-F592 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, V622-V622I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, H625- H625N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, S640-S640F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Y660-Y660H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, I666- I666 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G667-G667 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A668-A668 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, G669-G669 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, I670-I670 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, C671-C671 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A672-A672 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, S673-S673 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Y674-Y674 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q675-Q675H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L752-L752F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, N777-N777 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, I794-I794T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L822-L822 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L822-L822F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F823-F823 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A845-A845V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A846-A846T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A846-A846V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, I850-I850T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P862-P862S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q913-Q913 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A930-A930 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q954-Q954Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F970-F970L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, S974-S974L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, V987-V987F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A989-A989V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, K1038-K1038E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, C1043-C1043 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, H1048-H1048Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L1049-L1049F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P1053-P1053S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, H1058-H1058Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, V1060-V1060I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F1103-F1103S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, I1130-I1130L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, D1146-D1146H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q1208-Q1208 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q1208-Q1208H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, W1214-W1214C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, F1220-F1220 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, C1254-C1254 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E1258-E1258H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E1258-E1258Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P1263-P1263L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L5-L5F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L5-L5 Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, C15-C15F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Q23-Q23 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A67-A67V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F79-F79 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, D88-D88G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E132-E132 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F133-F133 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, D138-D138Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P139-P139 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F140-F140 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L141-L141 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, G142-G142 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V143-V143 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y144-Y144 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y145-Y145 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, H146-H146 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, H146-H146Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, W152-W152L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, M153-M153I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A243-A243 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L244-L244 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, R346-R346T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K356-K356T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, T376-T376 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F377-F377 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K444-K444S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V503-V503A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y505-Y505N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, R509-R509T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K528-K528E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, T547-T547K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A570-A570T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, T572-T572I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, D574-D574N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L611-L611P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, G639-G639V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, G669-G669 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, I670-I670N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, C671-C671 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A672-A672 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, S673-S673 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y674-Y674 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Q675-Q675H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A694-A694S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, T859-T859 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V860-V860 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A879-A879V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A893-A893S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K921-K921 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V951-V951L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A956-A956E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V987-V987F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, R1019-R1019I Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y1067-Y1067H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F1089-F1089S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, F1095-F1095L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E1150-E1150G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, M1229-M1229I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L1244-L1244 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K1245-K1245 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, C1254-C1254 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, F32-F32 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, R78-R78S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, F133-F133S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, D138-D138Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P139-P139 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, F140-F140 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, L141-L141 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G142-G142 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, V143-V143 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Y144-Y144 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Y145-Y145 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, H146-H146 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, N148-N148 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, I210-I210N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, N211-N211 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P330-P330S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P337-P337H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, K356-K356R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, K356-K356T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T376-T376 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, F377-F377 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, D420-D420N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G446-G446D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G446-G446R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G476-G476R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, N481-N481K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Y489-Y489H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G496-G496V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Y505-Y505N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, L513-L513F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, L517-L517F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T547-T547K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T572-T572I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, S591-S591F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G593-G593V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P631-P631S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Q644-Q644 Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, A647-A647S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Q675-Q675H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T676-T676I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, K795-K795 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Q872-Q872 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T883-T883I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, A899-A899C Frameshift mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, D979-D979V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, V987-V987F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Q1002-Q1002 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, A1020-A1020V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, H1048-H1048Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, F1103-F1103V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T1117-T1117I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, S1123-S1123P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, I1227-I1227 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, C1254-C1254 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7, Day 14 and Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples above the threshold for the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the \\>5% threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein compared to Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field, and represents participants who had Baseline and post-Baseline sequence available. 'Number Analyzed' signifies participants evaluable for the specified time points and codons at the \\>5% allelic frequency."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'classes': [{'title': 'Day 7, G75-G75V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, S373-S373P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q675-Q675H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, L752-L752F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A845-A845V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, A846-A846T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, Q913-Q913 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 7, P1053-P1053S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L5-L5F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y144-Y144 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, E340-E340V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, K356-K356T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, V503-V503A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y505-Y505N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A570-A570T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, T572-T572I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, D574-D574N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, I670- I670N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, C671-C671 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A672-A672 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, S673-S673 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Y674-Y674 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, A956-A956E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, L1244-L1244 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Y144-Y144 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, I210-I210N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, N211-N211 Deletion mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P337-P337S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, E340-E340V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, K356-K356R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, D420-D420N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, G446-G446D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, N481-N481K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T572-T572I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, P631-P631S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, A647-A647S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, T676-T676I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Q1002-Q1002 Stop codon mutation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 7, Day 14 and Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples with viral load above the threshold of the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the threshold for consensus sequence generation that were not present in the Baseline sequence, AA changes in the SARS-CoV-2 spike protein consensus sequence (\\>50%) from Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field, and represents participants who had Baseline and post-Baseline sequence available. 'Number Analyzed' signifies participants evaluable for the specified time points and codons at the \\>50% allelic frequency."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This was a prospective cohort study amongst immunocompromised non-hospitalized participants treated with sotrovimab as part of standard clinical care to monitor the emergence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike viral variants.', 'preAssignmentDetails': 'A total of 217 participants were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotrovimab 500 mg IV', 'description': 'Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '15.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}]}]}, {'title': 'De-identified', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Few race categories (with 0\\<n\\<11) are combined into one 'De-identified' category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-24', 'size': 1478862, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-10T09:04', 'hasProtocol': True}, {'date': '2023-07-18', 'size': 2168314, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-10T09:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a prospective cohort study which will enroll IC non-hospitalized participants receiving sotrovimab treatment as per standard of clinical care for COVID-19 in sentinel sites.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2022-03-30', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-10', 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7', 'timeFrame': 'At Day 7', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by Next generation sequencing (NGS) analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the amino acid (AA) sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 7.'}, {'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14', 'timeFrame': 'At Day 14', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 14.'}, {'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28', 'timeFrame': 'At Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 28.'}, {'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7', 'timeFrame': 'At Day 7', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 7.'}, {'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14', 'timeFrame': 'At Day 14', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 14.'}, {'measure': 'Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28', 'timeFrame': 'At Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 28.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI)', 'timeFrame': 'Up to Day 28', 'description': 'SARS-CoV-2 VOC is defined by World health Organization(WHO) that meets definition of VUI and through a comparative assessment, has been demonstrated to be associated with 1 or more of following changes at degree of global public health(GPH) significance: increase in transmissibility or detrimental change in COVID-19 epidemiology, OR increase in virulence or change in clinical disease presentation, OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics. SARS-CoV-2 VUI is defined by WHO as a variant:with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune, diagnostic or therapeutic escape and identified to cause significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest emerging risk to GPH.'}, {'measure': 'Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'timeFrame': 'At Day 7, Day 14, and Day 28', 'description': 'The number of participants that had undetectable viral load in nasal/oropharyngeal swabs was determined by quantitative reverse transcription-polymerase chain reaction (qRT/PCR) at Day 7, Day 14, and Day 28. Participants with major protocol deviation (out of visit window/samples received late/return more samples than expected) at specific visits were excluded from analysis.'}, {'measure': 'Number of Participants With All Cause Hospital Stay', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized due to any cause have been reported.'}, {'measure': 'Number of Participants With COVID-19 Related Hospital Stay', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized due to COVID-19 have been reported.'}, {'measure': 'Number of Participants Requiring New or Increased Oxygen Support (Supplemental Oxygen [Not High Flow]), Non-invasive Ventilation or High-flow, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants required new or increased oxygen support (supplemental oxygen \\[not high flow\\]), non-invasive ventilation or high-flow, invasive mechanical ventilation or ECMO have been reported.'}, {'measure': 'Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized in ICU due to any cause have been reported.'}, {'measure': 'Number of Participants With COVID-19 Related ICU Hospital Stay', 'timeFrame': 'Up to Day 28', 'description': 'Number of participants hospitalized in ICU due to COVID-19 have been reported.'}, {'measure': 'Number of Participants Who Died Due to Any Cause Through Day 28', 'timeFrame': 'Up to Day 28', 'description': 'Data for number of participants who died due to any cause through Day 28 have been reported.'}, {'measure': 'Number of Participants Who Died Due to COVID-19 Through Day 28', 'timeFrame': 'Up to Day 28', 'description': 'Data for number of participants who died due to COVID-19 have been reported.'}, {'measure': 'Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%', 'timeFrame': 'At Day 7, Day 14 and Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples above the threshold for the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the \\>5% threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein compared to Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.'}, {'measure': 'Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%', 'timeFrame': 'At Day 7, Day 14 and Day 28', 'description': 'SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples with viral load above the threshold of the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the threshold for consensus sequence generation that were not present in the Baseline sequence, AA changes in the SARS-CoV-2 spike protein consensus sequence (\\>50%) from Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS CoV-2', 'LUNAR', 'Coronavirus disease 2019 (COVID-19)', 'Pandemic', 'Sotrovimab', 'Monoclonal antibody', 'Immunocompromised (IC)'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '35780162', 'type': 'BACKGROUND', 'citation': 'Case JB, Mackin S, Errico JM, Chong Z, Madden EA, Whitener B, Guarino B, Schmid MA, Rosenthal K, Ren K, Dang HV, Snell G, Jung A, Droit L, Handley SA, Halfmann PJ, Kawaoka Y, Crowe JE Jr, Fremont DH, Virgin HW, Loo YM, Esser MT, Purcell LA, Corti D, Diamond MS. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022 Jul 2;13(1):3824. doi: 10.1038/s41467-022-31615-7.'}]}, 'descriptionModule': {'briefSummary': 'Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission.\n\nThis genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be adult and of greater than or equal to (\\>=) 18 years of age or older at the time of consent\n* Participants must be immunocompromised (IC) population eligible to receive sotrovimab\n* A positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 through clinical testing or routine screening undertaken as part of clinical management\n* Prescribed treatment with sotrovimab as standard of clinical care\n* Able to provide informed consent and willing to adhere to study-related procedures\n\nExclusion Criteria:\n\n* Participants who require hospitalization (related or not to COVID-19) at baseline\n* Participants who initiated sotrovimab therapy in inpatient settings\n* Participants unable to perform nasal/oropharyngeal sample collection\n* Blinded participants from other COVID-19 related trials'}, 'identificationModule': {'nctId': 'NCT05305651', 'acronym': 'LUNAR', 'briefTitle': 'Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Prospective Cohort Study to Monitor the Emergence of SARS-CoV-2 Spike Viral Variants in Immunocompromised Non-hospitalized Patients Exposed to Sotrovimab in Great Britain: LUNAR Study', 'orgStudyIdInfo': {'id': '218407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants receiving Sotrovimab', 'description': 'Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites', 'interventionNames': ['Drug: Sotrovimab']}], 'interventions': [{'name': 'Sotrovimab', 'type': 'DRUG', 'description': 'Sotrovimab dose and administration per standard of clinical care', 'armGroupLabels': ['Participants receiving Sotrovimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'B15 2GW', 'city': 'EdgbastonBirmingham', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site'}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'PL6 5FP', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', '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': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}