Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT04456959
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
InO - A Retrospective Study of UK Patients With Leukaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080045', 'term': 'Inotuzumab Ozogamicin'}], 'ancestors': [{'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': "Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.", 'eventGroups': [{'id': 'EG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'deathsNumAffected': 19, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'At least one line of prior chemotherapy recorded', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Not recorded', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Number of Lines of Salvage Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No salvage therapy', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'At least one line of prior HSCT recorded', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No prior HSCT', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Not recorded', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Type of Conditioning Regimen for Each HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'High-dose intensity myeloablative', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not known', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Reduced intensity/ non-myeloablative', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Treated Previously With Blinatumomab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Prior treatment with blinatumomab', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No prior treatment with Blinatumomab', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Participants with prior CAR T-Cell therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Participants with no prior CAR T-Cell therapy', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not recorded', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Total Duration of Treatment With Inotuzumab Ozogamicin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '52.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, total duration of InO treatment was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Received Total of 1 Cycle', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Received Total of 2 Cycles', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Received Total of 3 Cycles', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Received Total of 4 Cycles', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Received Total of 5 Cycles', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Received Total of 6 Cycles', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': '0 Cycle Interrupted', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '1 Cycle Interrupted', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '2 Cycle Interrupted', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Cycle 1: Cycle was not Interrupted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1: Interrupted Due to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1: Interrupted Due to Neutropenia and Severe Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1: Interrupted Due to SARS-CoV 2 infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: Cycle was not Interrupted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: Interrupted Due to Liver Toxicity TRAE(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: Cycle was not Interrupted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: Interrupted Due to Transferred to Another Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Cycle 1: 0.8 milligram per meter square (mg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1: 1.8 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: 1.0 mg/m2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: 1.2 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: 1.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: 1.8 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: 1.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: 1.8 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4: 0.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4: 1.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: 1.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6: 1.5 mg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to prescribed starting InO dose, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Participants with no dose modification', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No data recorded', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Not Treated With Concomitant Azole Antifungal Therapy', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Treated With Concomitant Azole Antifungal Therapy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Duration of Concomitant Azole Antifungal Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or (if unavailable in the records) as less than (\\<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to \\[\\>=\\] 100\\*10\\^9 cells per liter \\[/L\\] and absolute neutrophil counts \\[ANC\\] \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CRi was defined as documented in medical records or (if unavailable in the records) \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\* 10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CR/CRi by the End of InO Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Median Time to CR/CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \\<1\\*10\\^-4 (\\<0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Negative MRD Classified Per InO Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '3 and above', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \\<1\\*10\\^-4 (\\<0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Classified According to Their Cause of Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Acute Lymphoblastic Leukaemia', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Pneumonia', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'SAR COV 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Subarachnoid/Intraparenchymal Hemorrhage Stroke', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Veno-Occlusive Disease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to their cause of death were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'comment': 'Upper limit of 95% CI could not be estimated because there were insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '97.6'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '45.1', 'upperLimit': '81.8'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '24.8', 'upperLimit': '62.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9/L and ANC \\>=1\\*10\\^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9/L and ANC \\<1\\*10\\^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Relapse-free Survival (RFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.86', 'comment': 'Upper limit of 95% CI was not estimable due insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '4.93', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells /L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Time to Non-relapse Mortality (NRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.69', 'comment': 'Upper limit of 95% CI was not estimable due insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '5.88', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall number of Participants" signifies evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Chemotherapy', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'HSCT', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'CAR-T cell therapy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'HSCT: CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'HSCT: CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HSCT: Not Known', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CAR-T cell therapy: CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'CAR-T cell therapy: CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CAR-T cell therapy: PD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CAR-T cell therapy: Not Known', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab: CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab: Not Recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab: PD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab: SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: Not Recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: PD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other Chemotherapy: SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not \\>50%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each category."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Survived Post InO Blinatumomab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who survived at completion of InO treatment were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Participants With VOD/SOS', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Participants Not With VOD/SOS', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Spironolactone', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Ursodeoxycholic Acid', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Interrupted InO Treatment Due to VOD/SOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate Severity VOD/SOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': "Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included the medical records extracted for the purpose of the study from all eligible participants who were included in the study and had at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'title': 'Antibiotics/ Intensive Therapy Unit', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'High dose septrin + Caspofungi', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': "AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with Grade 3 or 4 TRAE."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Significant Risk Factors for VOD/SOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'classes': [{'title': 'Number of alkylating agents:1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Number of alkylating agents: 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Busulfan-containing regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Last bilirubin concentration prior to follow-up HSCT: <ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Last bilirubin concentration prior to follow-up HSCT: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Age: <55 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Age: >55 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Last ALT concentration prior to follow-up HSCT: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Last AST concentration prior to follow-up HSCT: ≤1.5 ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Last AST concentration prior to follow-up HSCT: Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Experienced VOD/SOS: Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Experienced VOD/SOS: No', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who initiated treatment with inotuzumab ozogamicin (InO) for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), in real world settings as a part of routine clinical care, between June 2016 and January 2021, were included. Data of these participants, were retrieved from hospital records and observed in this retrospective, observational study for approximately 1 year duration.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Inotuzumab Ozogamicin (InO)', 'description': 'Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46.8', 'spread': '19.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Time from ALL Diagnosis to Index Date', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Here, time from ALL diagnosis to index date was reported. Index date: date of initiation of the first cycle of InO.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS)', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Not recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG PS is used to measure quality of life of oncology participants with scores ranging from 0 to 5;where 0= fully active, able to carry on all pre-disease performance without restriction;1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work;2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\\>)50 percent (%) of waking hours;3= capable of only limited self-care, confined to bed or chair \\>50% of waking hours;4= completely disabled, cannot carry on any self-care, totally confined to bed or chair;5= dead.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Their Phase of Disease at Index Date', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'First relapse', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Second relapse', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Third relapse', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Fourth or greater relapse', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'CR', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants are classified according to phase of ALL disease: complete remission (CR), 1st relapse, 2nd relapse, 3rd relapse, 4th or greater relapse. Remission = either the reduction or disappearance of the signs and symptoms of a disease. Relapse = return of a disease or the signs and symptoms of a disease after a period of improvement. Index date: date of initiation of the first cycle of InO.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Not known', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants are classified according to their history of liver disease prior to index date, as 1) No = no previous liver disease history, 2) Yes = previous liver disease history and 3) Not know. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of Positive Cell Blasts (CD22 expression test)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '29.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this baseline characteristic.'}, {'title': 'Number of Participants According to ALL Mutation Types', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': '(1;19)(q23;p13)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'BCR-ABL', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Complex karyotype', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Cytogenetics failed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'ETV6 Rearrangement', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Gain 18 centromere', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Gain part of chr 5', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Known', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Relapse with clonal evolution', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 't(8:14)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants were classified per ALL mutation type.', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Platelet Counts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95.9', 'spread': '76.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells*10^9 per liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Absolute Neutrophil Counts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells*10^9 per liter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this baseline characteristic.'}, {'title': 'Blood Alanine Aminotransferase (ALT) Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37.9', 'spread': '35.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'International units per liter (IU/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Aspartate Aminotransferase (AST) Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this baseline characteristic.'}, {'title': 'Blood Bilirubin Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this baseline characteristic.'}, {'title': 'Blood Albumin Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Gamma Glutamyl Transferase (GGT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74.8', 'spread': '82.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this baseline characteristic.'}, {'title': 'Blood Alkaline Phosphatase (ALP) Levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '112.7', 'spread': '95.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here number analyzed signifies participants evaluable for this characteristic.'}, {'title': 'Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not known', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Here, number of participants are classified according to number of relapses of ALL relapse prior to index date. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) comprised of medical records extracted for the purpose of the study from all eligible participants who were included in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-18', 'size': 929888, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-27T15:44', 'hasProtocol': True}, {'date': '2020-06-16', 'size': 2748488, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-27T15:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-27', 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported.'}, {'measure': 'Number of Participants According to Number of Lines of Salvage Therapy', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported.'}, {'measure': 'Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT)', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.'}, {'measure': 'Number of Participants According to Type of Conditioning Regimen for Each HSCT', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported.'}, {'measure': 'Number of Participants Who Were Treated Previously With Blinatumomab', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.'}, {'measure': 'Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies', 'timeFrame': 'Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.'}], 'secondaryOutcomes': [{'measure': 'Total Duration of Treatment With Inotuzumab Ozogamicin', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, total duration of InO treatment was reported.'}, {'measure': 'Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.'}, {'measure': 'Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.'}, {'measure': 'Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.'}, {'measure': 'Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to prescribed starting InO dose, were reported.'}, {'measure': 'Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.'}, {'measure': 'Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.'}, {'measure': 'Duration of Concomitant Azole Antifungal Therapy', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.'}, {'measure': 'Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or (if unavailable in the records) as less than (\\<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to \\[\\>=\\] 100\\*10\\^9 cells per liter \\[/L\\] and absolute neutrophil counts \\[ANC\\] \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CRi was defined as documented in medical records or (if unavailable in the records) \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\* 10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Number of Participants With CR/CRi by the End of InO Treatment', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Median Time to CR/CRi', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \\<1\\*10\\^-4 (\\<0.01%) of bone marrow nucleated cells. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Number of Participants Who Achieved Negative MRD Classified Per InO Cycles', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Negative MRD (among those who had CR/CRi) was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \\<1\\*10\\^-4 (\\<0.01%) of bone marrow nucleated cells. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease.'}, {'measure': 'Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation', 'timeFrame': 'At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.'}, {'measure': 'Number of Participants Classified According to Their Cause of Death', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to their cause of death were reported.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis.'}, {'measure': 'Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation', 'timeFrame': 'At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'Relapse free survival: the time from the start of treatment to earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9/L and ANC \\>=1\\*10\\^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9/L and ANC \\<1\\*10\\^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L.'}, {'measure': 'Relapse-free Survival (RFS)', 'timeFrame': 'From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells /L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L.'}, {'measure': 'Time to Non-relapse Mortality (NRM)', 'timeFrame': 'Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.'}, {'measure': 'Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies.'}, {'measure': 'Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'CR was defined as documented in medical records or as \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets \\>=100\\*10\\^9 cells/L and ANC \\>=1\\*10\\^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or \\<5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets \\<100\\*10\\^9 cells/L and ANC \\<1\\*10\\^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of \\>5\\*10\\^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not \\>50%.'}, {'measure': 'Number of Participants Who Survived Post InO Blinatumomab Treatment', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, number of participants who survived at completion of InO treatment were reported.'}, {'measure': 'Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.'}, {'measure': 'Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.'}, {'measure': 'Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.'}, {'measure': 'Number of Participants With Interrupted InO Treatment Due to VOD/SOS', 'timeFrame': 'Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.'}, {'measure': 'Number of Participants With Moderate Severity VOD/SOS', 'timeFrame': 'Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study', 'description': 'VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.'}, {'measure': 'Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': "Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records."}, {'measure': 'Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': "AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records."}, {'measure': 'Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study'}, {'measure': 'Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT', 'timeFrame': 'Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study'}, {'measure': 'Number of Participants With Significant Risk Factors for VOD/SOS', 'timeFrame': 'From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study', 'description': 'In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Precursor Cell Lymphoblastic Leukemia-Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=X9001222', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed/refractory Acute Lymphoblastic Leukemia who are aged 18 and over and initiated Inotuzumab Ozogamicin between 1st of June 2016 and date of data collection and received treatment via NHS commissioning, via the Compassionate Use Programme, or via private purchase.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with relapsed/refractory ALL.\n* Patients who initiated InO between 1st of June 2016 and date of data collection.\n* Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase.\n* Patient aged ≥18 years old at initiation of InO treatment\n\nExclusion Criteria:\n\n* Patients initiated on treatment with InO at a different hospital than the ones selected in this study.\n* Patients with \\<3 months of follow-up since index date, unless death occurs \\<3 months from index date.'}, 'identificationModule': {'nctId': 'NCT04456959', 'acronym': 'InO', 'briefTitle': 'InO - A Retrospective Study of UK Patients With Leukaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Retrospective Chart Review of UK Patients With Relapsed/Refractory Acute Lymphoblastic Leukaemia Treated With Inotuzumab Ozogamicin, a Real World Research Study', 'orgStudyIdInfo': {'id': 'X9001222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult R/R ALL patients who have received InO', 'description': 'Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time.', 'interventionNames': ['Drug: Inotuzumab Ozogamicin']}], 'interventions': [{'name': 'Inotuzumab Ozogamicin', 'type': 'DRUG', 'otherNames': ['CMC-544'], 'description': 'Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.', 'armGroupLabels': ['Adult R/R ALL patients who have received InO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS1 3NU', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust of Fulham Road', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TA1 5DA', 'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}