Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-14 @ 3:48 PM
Study NCT ID:
NCT05923112
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BESPONSA Injection 1 mg Special Investigation
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'}]}}, '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 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}, 'limitationsAndCaveats': {'description': 'Although this study is an all-case surveillance, the informed consent rate for disclosure of study results was 36%. It is considered that the differences observed between the results of the all-case surveillance and those obtained from patients who provided informed consent may be attributed to variations in baseline characteristics and reduced statistical precision. The main factor is presumed to be the smaller sample size, which led to wider confidence intervals and shifts in point estimates.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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 serious and non-serious events during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.", 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 71, 'seriousNumAtRisk': 136, 'deathsNumAffected': 21, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}], 'seriousEvents': [{'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Cytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Venoocclusive liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 13}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Acute lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 15}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Leukaemic infiltration extramedullary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J27.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Incidence of Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'title': 'ADR', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'SADR', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to BESPONSA Injection 1mg in a participant who received BESPONSA Injection 1mg. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: results in death; is life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (All CTCAE Grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.008', 'ciLowerLimit': '0.258', 'ciUpperLimit': '3.940', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.497', 'ciUpperLimit': '2.177', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.084', 'ciLowerLimit': '0.317', 'ciUpperLimit': '3.710', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.212', 'ciLowerLimit': '0.536', 'ciUpperLimit': '2.740', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.091', 'ciLowerLimit': '0.247', 'ciUpperLimit': '4.827', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.137', 'ciLowerLimit': '0.461', 'ciUpperLimit': '2.801', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.409', 'ciLowerLimit': '0.493', 'ciUpperLimit': '4.030', 'estimateComment': 'Risk Ratio of hepatic impairment "present" to "absent"', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.096', 'ciLowerLimit': '0.301', 'ciUpperLimit': '3.994', 'estimateComment': 'Risk Ratio of past medical history - Hepatitis or hepatic disease "present" to "absent"', 'groupDescription': 'Subgroup analyses of past medical history - Hepatitis or hepatic disease', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.409', 'ciLowerLimit': '0.493', 'ciUpperLimit': '4.030', 'estimateComment': 'Risk Ratio of present medical history - Hepatitis or hepatic disease "present" to "absent"', 'groupDescription': 'Subgroup analyses of present medical history - Hepatitis or hepatic disease', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.954', 'ciLowerLimit': '1.172', 'ciUpperLimit': '7.445', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.152', 'ciLowerLimit': '0.299', 'ciUpperLimit': '4.432', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.873', 'ciLowerLimit': '0.113', 'ciUpperLimit': '6.743', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.158', 'ciLowerLimit': '0.545', 'ciUpperLimit': '2.461', 'estimateComment': 'Risk Ratio of AST and ALT levels immediately before the start of this drug "either \\> 1.5 × the institutional upper limit normal range (IULN)" to "≤ 1.5 × IULN"', 'groupDescription': 'Subgroup analyses of AST and ALT levels immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.280', 'ciUpperLimit': '1.244', 'estimateComment': 'Risk Ratio of γ-GTP level immediately before the start of this drug "\\> 50 IU/L" to "≤ 50 IU/L"', 'groupDescription': 'Subgroup analyses of γ-GTP level immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.267', 'ciLowerLimit': '0.038', 'ciUpperLimit': '1.862', 'estimateComment': 'Risk Ratio of γ-GTP level immediately before the start of this drug "not performed" to "≤ 50 IU/L"', 'groupDescription': 'Subgroup analyses of γ-GTP level immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.413', 'ciLowerLimit': '0.201', 'ciUpperLimit': '0.849', 'estimateComment': 'Risk Ratio of platelet count immediately before the start of this drug "\\< 10 × 10⁴/μL" to "≥ 10 × 10⁴/μL"', 'groupDescription': 'Subgroup analyses of platelet count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.299', 'ciLowerLimit': '0.075', 'ciUpperLimit': '1.194', 'estimateComment': 'Risk Ratio of peripheral blast count immediately before the start of this drug "\\> 1000 /μL" to "≤ 1000 /μL"', 'groupDescription': 'Subgroup analyses of peripheral blast count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.415', 'ciLowerLimit': '0.917', 'ciUpperLimit': '6.362', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.688', 'ciLowerLimit': '0.612', 'ciUpperLimit': '4.655', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.901', 'ciLowerLimit': '0.408', 'ciUpperLimit': '1.990', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups were determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; Eastern Cooperative Oncology Group performance status (ECOG PS); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels; gamma glutamyl transpeptidase (γ-GTP) level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (CTCAE Grade 3 or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.616', 'ciLowerLimit': '0.086', 'ciUpperLimit': '4.391', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.188', 'ciUpperLimit': '1.491', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.012', 'ciLowerLimit': '0.217', 'ciUpperLimit': '4.723', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.905', 'ciLowerLimit': '0.316', 'ciUpperLimit': '2.594', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.682', 'ciLowerLimit': '0.085', 'ciUpperLimit': '5.455', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.789', 'ciLowerLimit': '0.267', 'ciUpperLimit': '2.335', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.583', 'ciLowerLimit': '0.845', 'ciUpperLimit': '7.900', 'estimateComment': 'Risk Ratio of hepatic impairment "present" to "absent"', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.131', 'ciUpperLimit': '6.163', 'estimateComment': 'Risk Ratio of past medical history - Hepatitis or hepatic disease "present" to "absent"', 'groupDescription': 'Subgroup analyses of past medical history - Hepatitis or hepatic disease', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.583', 'ciLowerLimit': '0.845', 'ciUpperLimit': '7.900', 'estimateComment': 'Risk Ratio of present medical history - Hepatitis or hepatic disease "present" to "absent"', 'groupDescription': 'Subgroup analyses of present medical history - Hepatitis or hepatic disease', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.769', 'ciLowerLimit': '0.796', 'ciUpperLimit': '9.630', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '0.418', 'ciUpperLimit': '8.827', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.615', 'ciLowerLimit': '0.184', 'ciUpperLimit': '2.062', 'estimateComment': 'Risk Ratio of AST and ALT levels immediately before the start of this drug "either \\> 1.5 × the institutional upper limit normal range (IULN)" to "≤ 1.5 ×IULN"', 'groupDescription': 'Subgroup analyses of AST and ALT levels immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.656', 'ciLowerLimit': '0.249', 'ciUpperLimit': '1.729', 'estimateComment': 'Risk Ratio of γ-GTP level immediately before the start of this drug "\\> 50 IU/L" to "≤ 50 IU/L"', 'groupDescription': 'Subgroup analyses of γ-GTP level immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of γ-GTP level immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of γ-GTP level immediately before the start of this drug "not performed" to "≤ 50 IU/L"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.707', 'ciLowerLimit': '0.273', 'ciUpperLimit': '1.836', 'estimateComment': 'Risk Ratio of platelet count immediately before the start of this drug "\\< 10 × 10⁴/μL" to "≥ 10 × 10⁴/μL"', 'groupDescription': 'Subgroup analyses of platelet count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.245', 'ciLowerLimit': '0.034', 'ciUpperLimit': '1.790', 'estimateComment': 'Risk Ratio of peripheral blast count immediately before the start of this drug "\\> 1000 /μL" to "≤ 1000 /μL"', 'groupDescription': 'Subgroup analyses of peripheral blast count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.927', 'ciLowerLimit': '0.832', 'ciUpperLimit': '10.294', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.296', 'ciUpperLimit': '5.279', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.545', 'ciLowerLimit': '0.588', 'ciUpperLimit': '4.058', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator.\n\nADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; ECOG PS; AST and ALT levels; γ-GTP level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Myelosuppression (ADRs)/ (All CTCAE Grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.528', 'ciLowerLimit': '0.144', 'ciUpperLimit': '1.939', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.316', 'ciLowerLimit': '0.849', 'ciUpperLimit': '2.041', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.084', 'ciLowerLimit': '0.500', 'ciUpperLimit': '2.351', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.293', 'ciLowerLimit': '0.781', 'ciUpperLimit': '2.142', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.455', 'ciLowerLimit': '0.120', 'ciUpperLimit': '1.715', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.605', 'ciUpperLimit': '1.653', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.099', 'ciLowerLimit': '0.542', 'ciUpperLimit': '2.228', 'estimateComment': 'Risk Ratio of hepatic impairment "present" to "absent"', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.069', 'ciLowerLimit': '0.667', 'ciUpperLimit': '1.714', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.909', 'ciLowerLimit': '0.485', 'ciUpperLimit': '1.705', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.459', 'ciLowerLimit': '0.125', 'ciUpperLimit': '1.688', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.889', 'ciLowerLimit': '0.580', 'ciUpperLimit': '1.362', 'estimateComment': 'Risk Ratio of white blood cell count immediately before the start of this drug "≥ 4000/mm³" to "\\< 4000/mm³"', 'groupDescription': 'Subgroup analyses of white blood cell count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.121', 'ciLowerLimit': '0.728', 'ciUpperLimit': '1.725', 'estimateComment': 'Risk Ratio of neutrophil count immediately before the start of this drug "≥ 2000/mm³" to "\\< 2000/mm³"', 'groupDescription': 'Subgroup analyses of neutrophil count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.639', 'ciUpperLimit': '1.536', 'estimateComment': 'Risk Ratio of platelet count immediately before the start of this drug "\\< 10 × 10⁴/μL" to "≥ 10 × 10⁴/μL"', 'groupDescription': 'Subgroup analyses of platelet count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.996', 'ciLowerLimit': '1.093', 'ciUpperLimit': '3.643', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.977', 'ciUpperLimit': '3.279', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.772', 'ciLowerLimit': '0.464', 'ciUpperLimit': '1.286', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Myelosuppression (ADRs)/ (CTCAE Grade 3 or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.584', 'ciLowerLimit': '0.158', 'ciUpperLimit': '2.159', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.104', 'ciLowerLimit': '0.667', 'ciUpperLimit': '1.826', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.973', 'ciLowerLimit': '0.410', 'ciUpperLimit': '2.311', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.088', 'ciLowerLimit': '0.624', 'ciUpperLimit': '1.897', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.545', 'ciLowerLimit': '0.141', 'ciUpperLimit': '2.108', 'estimateComment': 'Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.979', 'ciLowerLimit': '0.547', 'ciUpperLimit': '1.753', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.662', 'ciUpperLimit': '2.793', 'estimateComment': 'Risk Ratio of hepatic impairment "present" to "absent"', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.769', 'ciLowerLimit': '0.439', 'ciUpperLimit': '1.349', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.507', 'ciUpperLimit': '1.816', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.242', 'ciLowerLimit': '0.036', 'ciUpperLimit': '1.627', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.848', 'ciLowerLimit': '0.518', 'ciUpperLimit': '1.391', 'estimateComment': 'Risk Ratio of white blood cell count immediately before the start of this drug "≥ 4000/mm³" to "\\< 4000/mm³"', 'groupDescription': 'Subgroup analyses of white blood cell count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.945', 'ciLowerLimit': '0.578', 'ciUpperLimit': '1.547', 'estimateComment': 'Risk Ratio of neutrophil count immediately before the start of this drug "≥ 2000/mm³" to "\\< 2000/mm³"', 'groupDescription': 'Subgroup analyses of neutrophil count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.156', 'ciLowerLimit': '0.685', 'ciUpperLimit': '1.950', 'estimateComment': 'Risk Ratio of platelet count immediately before the start of this drug "\\< 10 × 10⁴/μL" to "≥ 10 × 10⁴/μL"', 'groupDescription': 'Subgroup analyses of platelet count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.195', 'ciLowerLimit': '1.113', 'ciUpperLimit': '4.329', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.667', 'ciLowerLimit': '0.821', 'ciUpperLimit': '3.384', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.004', 'ciLowerLimit': '0.586', 'ciUpperLimit': '1.719', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Infections (ADRs)/ (All CTCAE Grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.383', 'ciLowerLimit': '0.480', 'ciUpperLimit': '11.824', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.529', 'ciLowerLimit': '0.168', 'ciUpperLimit': '38.180', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.829', 'ciLowerLimit': '0.342', 'ciUpperLimit': '23.432', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.789', 'ciLowerLimit': '0.161', 'ciUpperLimit': '3.862', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of hepatic impairment "present" to "absent"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.196', 'ciUpperLimit': '4.355', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.070', 'ciUpperLimit': '5.840', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.386', 'ciLowerLimit': '0.048', 'ciUpperLimit': '3.107', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Infections (ADRs)/ (CTCAE Grade 3 or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.953', 'ciLowerLimit': '0.139', 'ciUpperLimit': '6.556', 'estimateComment': 'Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.529', 'ciLowerLimit': '0.168', 'ciUpperLimit': '38.180', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.132', 'ciLowerLimit': '0.106', 'ciUpperLimit': '12.119', 'estimateComment': 'Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.316', 'ciLowerLimit': '0.046', 'ciUpperLimit': '2.146', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of hepatic impairment "present" to "absent"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.462', 'ciLowerLimit': '0.043', 'ciUpperLimit': '4.928', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.091', 'ciUpperLimit': '10.079', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.772', 'ciLowerLimit': '0.083', 'ciUpperLimit': '7.207', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Hemorrhage (ADRs)/ (All CTCAE Grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of hepatic impairment', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of hepatic impairment "present" to "absent"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.923', 'ciLowerLimit': '0.059', 'ciUpperLimit': '14.352', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of ECOG PS before the start of this drug "≥ 2" to "1"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of ECOG PS before the start of this drug "not performed" to "1"'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'estimateComment': 'The risk ratio was reported as participants in this group are related to Category(A).', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of HSCT before the start of this drug "performed" to "not performed"'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 65 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[≥ 65 years, ≥ 15 to \\< 65 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "≥ 65 years" to "≥ 15 to \\< 65 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[≥ 55 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "≥ 55 years" to "≥ 18 to \\< 55 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[\\< 15 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "\\< 15 years" to "≥ 15 to \\< 40 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}, {'groupIds': ['OG000'], 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation', 'otherAnalysisDescription': 'Regarding Risk Ratio of salvage line of the induction treatment with this drug "3rd or later" to "1st", the risk ratio was reported as participants in this group are related to Category(B).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Hemorrhage (ADRs)/ (CTCAE Grade 3 or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'PRIMARY', 'title': 'Early Death After HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'title': 'Death after HSCT in participants who underwent HSCT after starting treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Death within 100 days post-HSCT in participants who died after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Death after > 100 days post-HSCT in participants who died after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.333', 'ciLowerLimit': '0.046', 'ciUpperLimit': '2.405', 'estimateComment': 'Risk Ratio of age "\\< 18 years" to "≥ 18 to \\< 55 years"', 'groupDescription': 'Subgroup analyses of age \\[\\< 18 years, ≥ 18 to \\< 55 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.340', 'ciUpperLimit': '3.560', 'estimateComment': 'Risk Ratio of age "≥ 40 years" to "≥ 15 to \\< 40 years"', 'groupDescription': 'Subgroup analyses of age \\[≥ 40 years, ≥ 15 to \\< 40 years\\]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.227', 'ciLowerLimit': '0.371', 'ciUpperLimit': '4.056', 'estimateComment': 'Risk Ratio of chromosome karyotype "Philadelphia chromosome positive" to "negative"', 'groupDescription': 'Subgroup analyses of chromosome karyotype', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.183', 'ciUpperLimit': '1.966', 'estimateComment': 'Risk Ratio of ECOG PS before the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.284', 'ciUpperLimit': '2.481', 'estimateComment': 'Risk Ratio of hemoglobin level immediately before the start of this drug "\\< 10 g/dL" to "≥ 10 g/dL"', 'groupDescription': 'Subgroup analyses of hemoglobin level immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '0.604', 'ciUpperLimit': '6.621', 'estimateComment': 'Risk Ratio of platelet count immediately before the start of this drug "\\< 10 × 10⁴/μL" to "≥ 10 × 10⁴/μL"', 'groupDescription': 'Subgroup analyses of platelet count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.917', 'ciLowerLimit': '0.278', 'ciUpperLimit': '3.026', 'estimateComment': 'Risk Ratio of myeloblast count immediately before the start of this drug "\\> 50%" to "≤ 50%"', 'groupDescription': 'Subgroup analyses of myeloblast count immediately before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.264', 'ciLowerLimit': '0.036', 'ciUpperLimit': '1.930', 'estimateComment': 'Risk Ratio of salvage line of the induction treatment with this drug "2nd" to "1st"', 'groupDescription': 'Subgroup analyses of salvage line of the induction treatment with this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.438', 'ciLowerLimit': '0.497', 'ciUpperLimit': '4.161', 'estimateComment': 'Risk Ratio of HSCT before the start of this drug "performed" to "not performed"', 'groupDescription': 'Subgroup analyses of HSCT before the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.616', 'ciLowerLimit': '0.187', 'ciUpperLimit': '2.030', 'estimateComment': 'Risk Ratio of type of the first HSCT after the start of this drug "allogeneic hematopoietic stem cell transplant with myeloablative conditioning" to "allogeneic hematopoietic stem cell transplant with nonmyeloablative conditioning"', 'groupDescription': 'Subgroup analyses of type of the first HSCT after the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.583', 'ciLowerLimit': '0.155', 'ciUpperLimit': '2.192', 'estimateComment': 'Risk Ratio of ECOG PS before conditioning for the first HSCT after the start of this drug "0" to "1"', 'groupDescription': 'Subgroup analyses of ECOG PS before conditioning for the first HSCT after the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.545', 'ciLowerLimit': '0.630', 'ciUpperLimit': '10.293', 'estimateComment': 'Risk Ratio of hemoglobin level before conditioning for the first HSCT after the start of this drug "\\< 10 g/dL" to "≥ 10 g/dL"', 'groupDescription': 'Subgroup analyses of hemoglobin level before conditioning for the first HSCT after the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.179', 'ciLowerLimit': '0.237', 'ciUpperLimit': '5.870', 'estimateComment': 'Risk Ratio of time from the date of final dose of this drug to the date of the first HSCT after the start of this drug "≥ 4 weeks to \\< 8 weeks" to "\\< 4 weeks"', 'groupDescription': 'Subgroup analyses of time from the date of final dose of this drug to the date of the first HSCT after the start of this drug', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.182', 'ciLowerLimit': '0.665', 'ciUpperLimit': '7.158', 'estimateComment': 'Risk Ratio of best overall response "progression or relapse" to "complete remission (CR) or complete remission with incomplete hematologic recovery (CRi)"', 'groupDescription': 'Subgroup analyses of best overall response', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}, {'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.538', 'ciLowerLimit': '0.392', 'ciUpperLimit': '6.037', 'estimateComment': 'Risk Ratio of MRD "test not performed" to "negativity achieved"', 'groupDescription': 'Subgroup analyses of minimal residual disease (MRD)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimation'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 100 days or greater than 100 days after the first HSCT after the start of BESPONSA 1 mg injection up to 52 weeks', 'description': 'Risk ratios for the proportion of participants with early death in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nParticipants in the safety analysis set who underwent HSCT after the start of BESPONSA Injection 1mg and have completed the study were included in the analysis. Early death after HSCT was defined as death occurring within 100 days after the first HSCT following the start of BESPONSA Injection 1mg. Early death was considered to be absent if the participant died on Day 101 or later, or was confirmed alive at the time of study completion/discontinuation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.'}, {'type': 'SECONDARY', 'title': 'Hematologic Remission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '52.9', 'upperLimit': '70.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 Weeks. However, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever was earlier, was entered.', 'description': 'The best overall response was evaluated for its clinical effect of hematologic remission during the observation period.\n\nThe proportions of CR or CRi and their 95% confidence intervals were determined.\n\nHowever, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever occurred earlier, was recorded.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The effectiveness analysis set excluded participants in the safety analysis set who had diseases that were outside the scope of the study. Participants without informed consent on publication of study results were excluded.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'classes': [{'categories': [{'measurements': [{'value': '10.28', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '16.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': "OS was defined and evaluated as the number of months from the start of BESPONSA Injection 1mg to all-cause death. The participant's survival status was confirmed at the time of completion or discontinuation of the study. The endpoint was censored on the day when participant's survival was last confirmed.\n\nFor time-to-event data, the median was determined using the Kaplan-Meier method.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The effectiveness analysis set excluded participants in the safety analysis set who had diseases that were outside the scope of the study. Participants without informed consent on publication of study results were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and overall survival (OS). The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo hematopoietic stem cell transplant (HSCT) within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for venoocclusive disease (VOD)/sinusoidal obstruction syndrome (SOS), and effectiveness was observed as survival time."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '383'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'No informed consent on publication of study results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '243'}]}]}], 'recruitmentDetails': '421 participants were considered to be enrolled because they used this drug after marketing. CRFs were collected from 383 of these participants. Although data were analyzed from 383 participants for all-case surveillance, only 136 participants provided informed consent for results disclosure and are reported in the record.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BESPONSA Injection 1mg (Inotuzumab Ozogamicin)', 'description': "Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<15 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '≥15 and <65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': '≥65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '67', '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.'}], 'populationDescription': '383 participants contributed to the all-case surveillance analysis, regardless of whether they consented to disclosure of results. 247 participants were excluded from the safety analysis set due to the following: protocol violation (4 participants) and no informed consent on publication of study results (243 participants). 136 participants who provided consent for results disclosure completed the study. Overall, the safety analysis set comprised of 136 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-12', 'size': 3840231, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-10T05:47', 'hasProtocol': True}, {'date': '2024-09-02', 'size': 4437657, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-10T05:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-06-20', 'resultsFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of Adverse Drug Reactions', 'timeFrame': 'From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to BESPONSA Injection 1mg in a participant who received BESPONSA Injection 1mg. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: results in death; is life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.'}, {'measure': 'The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (All CTCAE Grades)', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups were determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; Eastern Cooperative Oncology Group performance status (ECOG PS); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels; gamma glutamyl transpeptidase (γ-GTP) level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (CTCAE Grade 3 or Higher)', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator.\n\nADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; ECOG PS; AST and ALT levels; γ-GTP level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Myelosuppression (ADRs)/ (All CTCAE Grades)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Myelosuppression (ADRs)/ (CTCAE Grade 3 or Higher)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Infections (ADRs)/ (All CTCAE Grades)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Infections (ADRs)/ (CTCAE Grade 3 or Higher)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Hemorrhage (ADRs)/ (All CTCAE Grades)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both.\n\nADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'The Incidence of Hemorrhage (ADRs)/ (CTCAE Grade 3 or Higher)', 'timeFrame': 'From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participants', 'description': 'Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \\> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.'}, {'measure': 'Early Death After HSCT', 'timeFrame': 'Within 100 days or greater than 100 days after the first HSCT after the start of BESPONSA 1 mg injection up to 52 weeks', 'description': 'Risk ratios for the proportion of participants with early death in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category.\n\nParticipants in the safety analysis set who underwent HSCT after the start of BESPONSA Injection 1mg and have completed the study were included in the analysis. Early death after HSCT was defined as death occurring within 100 days after the first HSCT following the start of BESPONSA Injection 1mg. Early death was considered to be absent if the participant died on Day 101 or later, or was confirmed alive at the time of study completion/discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Hematologic Remission Rate', 'timeFrame': '52 Weeks. However, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever was earlier, was entered.', 'description': 'The best overall response was evaluated for its clinical effect of hematologic remission during the observation period.\n\nThe proportions of CR or CRi and their 95% confidence intervals were determined.\n\nHowever, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever occurred earlier, was recorded.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'No HSCT: up to 52 weeks, HSCT: up to 104 weeks', 'description': "OS was defined and evaluated as the number of months from the start of BESPONSA Injection 1mg to all-cause death. The participant's survival status was confirmed at the time of completion or discontinuation of the study. The endpoint was censored on the day when participant's survival was last confirmed.\n\nFor time-to-event data, the median was determined using the Kaplan-Meier method."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug use investigation in Japan'], 'conditions': ['Acute Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1931024', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.\n\nRegistration criteria for this study is all patients who starting BESPONSA in Japan from its launch to the market to April 30, 2020.\n\nAll patients in this study will receive BESPONSA according to the prescriptions.\n\nPatients will be followed up as follow.\n\n* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.\n* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who received BESPONSA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients prescribed BESPONSA\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05923112', 'briefTitle': 'BESPONSA Injection 1 mg Special Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION', 'orgStudyIdInfo': {'id': 'B1931024'}, 'secondaryIdInfos': [{'id': 'NCT05923112', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}