Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 6:53 PM
Study NCT ID:
NCT05166135
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Latin American Real-world Study in Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.', 'otherNumAtRisk': 518, 'deathsNumAtRisk': 518, 'otherNumAffected': 2, 'seriousNumAtRisk': 518, 'deathsNumAffected': 392, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 1, 'seriousNumAtRisk': 71, 'deathsNumAffected': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 518, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vancomycin infusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 518, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 518, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 518, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants According to Health Insurance Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Public', 'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to type of health insurance (public or private) were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Country of Residence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': 'Argentina', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Brazil', 'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Chile', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Colombia', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Family History of Hematological Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who had a family history of hematological malignancies were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Prior Exposure to Toxic Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Prior Exposure to a High Dose of Radiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Reason for Exposure to High Dose of Radiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': 'Therapeutic radiation for other cancers', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Accidental exposures', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Bleeding History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with bleeding history were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tobacco Consumption Habits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': 'Non-smoker', 'measurements': [{'value': '343', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': "ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \\>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2, 3 and 4) was reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study., Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Karnofsky Performance Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': '100', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': '90', 'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': '80', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '70', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '60', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '50', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '40', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '30', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '20', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': "Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score was 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Score:100=normal no complaints; no disease evidence,90=able to carry normal activity; minor signs/symptoms of disease,80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry normal activity, 60=required occasional assistance, able to care for personal needs, 50=required considerable assistance \\& frequent medical care, 40=disabled; required special care/assistance,30=severely disabled; hospital admission indicated;20=very sick; hospital admission necessary,10=moribund and 0=dead.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Year of Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': '2015', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '2016', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '2017', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '2018', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': '2019', 'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Classification for Standard Newly AML Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Fit', 'measurements': [{'value': '390', 'groupId': 'OG000'}]}, {'title': 'Unfit', 'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Fit', 'measurements': [{'value': '217', 'groupId': 'OG000'}]}, {'title': 'Unfit', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Fit', 'measurements': [{'value': '102', 'groupId': 'OG000'}]}, {'title': 'Unfit', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Fit', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Unfit', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Fit', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Unfit', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants classified as fit or unfit for the standard newly AML therapy according to different lines of treatment (LOT) were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. and 'Number Analyzed' signifies participants evaluable for the specified rows. Only newly AML participants were to be analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Drug Regimen Prescribed for Newly AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'Standard 7+3 (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}]}]}, {'title': 'HDAC (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDAC (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HMA (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'CLAG (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MEC (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MICE (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Standard 7+3 (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'HDAC (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'LDAC (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'HMA (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'CLAG (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MEC (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'MICE (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Standard 7+3 (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HDAC (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'LDAC (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'HMA (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'CLAG (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'MEC (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'MICE (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Standard 7+3 (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HDAC (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'LDAC (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HMA (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'CLAG (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'MEC (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'MICE (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Standard 7+3 (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'HDAC (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'LDAC (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'HMA (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'CLAG (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MEC (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'MICE (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for newly AML were reported by each line of treatment (LOT). Drug regimen included standard 7+3, Histone deacetylases (HDACs), Low-dose Cytarabine (LDAC), FLAG (fludarabine + high-dose cytarabine + G-CSF (Granulocyte colony-stimulating factor), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Hypomethylating agents (HMA), CLAG (Cladribine + Cytarabine + G-CSF), MEC (mitoxantrone, etoposide and intermediate dose cytarabine), MICE and other.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. Only newly AML participants were to be analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Hyper-CVAD (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'BFM (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Hyper-CVAD (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BFM (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Hyper-CVAD (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BFM (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Hyper-CVAD (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BFM (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hyper-CVAD (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BFM (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL were reported by each LOT is reported. Drug regimen included Hyper- CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter study group for ALL (GMALL), Group for Research on Adult Acute Lymphoblastic Leukemia (GRAAL), Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab, Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Other. One participant could be prescribed more than 1 drug regimen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. Only R/R B-cell ALL participants were to be analyzed for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'Gemtuzumab (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Midostaurin (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Venetoclax (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Gemtuzumab (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Midostaurin (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Venetoclax (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Gemtuzumab (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Midostaurin (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Venetoclax (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Gemtuzumab (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Midostaurin (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Venetoclax (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Gemtuzumab (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Midostaurin (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Venetoclax (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Regimen Type in Newly AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'Induction (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}]}]}, {'title': 'Consolidation (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Salvage (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Induction (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Consolidation (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Salvage (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Induction (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Consolidation (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Salvage (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Induction (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Consolidation (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Salvage (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Induction (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Consolidation (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Maintenance (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Salvage (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to drug regimen prescribed for newly AML is reported by each LOT. Induction was the first phase of treatment. Consolidation was given after the participant had recovered from induction. Maintenance was given to maintain the remission and further prevent a relapse. Salvage was used when a disease did not respond to all other standard treatments tried.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'The duration of treatment according to different treatment lines were reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Time to Next Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1 to LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '1.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '14.5'}]}]}, {'title': 'LOT2 to LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '13.5'}]}]}, {'title': 'LOT3 to LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.6'}, {'value': '2.4', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': 'NA'}]}]}, {'title': 'LOT4 to LOT5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '8.2'}, {'value': '2.7', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': 'NA'}]}]}, {'title': 'LOT5 to LOT6, LOT6 to LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': 'NA'}, {'value': '7.9', 'comment': 'Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 month', 'description': 'Time to next treatment was considered as the time from the start date of the front-line therapy to the start date of a subsequent line of therapy. Participants without a subsequent line of therapy were censored at study enrollment, last visit, last contact, or death, whichever comes first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Total Number of Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Total number of cycles according to each line of treatment is reported in this outcome measure.', 'unitOfMeasure': 'Cycles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Withdrew Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Reasons for Withdrawing Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Progression of the disease (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event-toxicity (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': "Participant's refusal to continue the treatment scheme (LOT1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cost-related or access barriers (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Progression of the disease (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event-toxicity (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': "Participant's refusal to continue the treatment scheme (LOT2)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cost-related or access barriers (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Progression of the disease (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event-toxicity (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': "Participant's refusal to continue the treatment scheme (LOT3)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cost-related or access barriers (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Progression of the disease (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event-toxicity (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': "Participant's refusal to continue the treatment scheme (LOT4)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cost-related or access barriers (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Progression of the disease (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event-toxicity (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "Participant's refusal to continue the treatment scheme (LOT5-LOT7)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cost-related or access barriers (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to reasons such as progression of the disease, Adverse event toxicity, participants refusal to continue the treatment scheme, cost related or access barriers and other for withdrawing regimen according to each line of treatment were reported in this outcome measure. One participant could have more than one reason for withdrawing regimen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants with reasons available for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Duration of Radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Dose of Radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '300', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as only one participants was analyzed.', 'groupId': 'OG000'}, {'value': '2267', 'spread': '1553', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as only one participants was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2400', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as only one participants was analyzed.', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.', 'unitOfMeasure': 'Rad', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Location of Application of Radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'CNS (cranial irradiation)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Total body irradiation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'CNS (cranial irradiation)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Total body irradiation', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'CNS (cranial irradiation)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Total body irradiation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'CNS (cranial irradiation)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Total body irradiation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'CNS (cranial irradiation)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Total body irradiation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Intrathecal Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Intrathecal chemotherapy (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Methotrexate (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Cytarabine (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dexamethasone (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intrathecal chemotherapy (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Methotrexate (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Cytarabine (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dexamethasone (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intrathecal chemotherapy (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Methotrexate (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Cytarabine (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dexamethasone (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intrathecal chemotherapy (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Methotrexate (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cytarabine (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dexamethasone (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intrathecal chemotherapy (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Methotrexate (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cytarabine (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dexamethasone (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to intrathecal chemotherapy such as methotrexate, cytarabine, prednisone, dexamethasone, other according to each line of treatment is reported in this outcome measure. One participant may receive more than one intrathecal chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Stem Cell Transplant (SCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with stem cell transplant were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Absolute Value of Hemoglobin Before Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '470', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure. Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of Hemoglobin After Start of Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of White Blood Cell Count Before Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.7', 'spread': '168.6', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '58.1', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '48.4', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '58.6', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '69.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '29.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': '10^9cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of White Blood Cell Count After Start of Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '32.4', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '70.2', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '40.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': '10^9cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Neutrophil Count (ANC) Before Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': '10^9cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Neutrophil Count (ANC) After Start of Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': '10^9cells per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of Blast Count Before Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '35.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '35.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of blast cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of Blast Count After Start of Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '29.1', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of blast cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of Platelets Count Before Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68613', 'spread': '75931', 'groupId': 'OG000'}, {'value': '69220', 'spread': '80225', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153362', 'spread': '141776', 'groupId': 'OG000'}, {'value': '115181', 'spread': '110273', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112035', 'spread': '120858', 'groupId': 'OG000'}, {'value': '91565', 'spread': '95696', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143263', 'spread': '122895', 'groupId': 'OG000'}, {'value': '69100', 'spread': '96956', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101231', 'spread': '113248', 'groupId': 'OG000'}, {'value': '77200', 'spread': '60318', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.', 'unitOfMeasure': '10^3 cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Absolute Value of Platelets Count After Start of Treatment Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'LOT1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105713', 'spread': '153196', 'groupId': 'OG000'}, {'value': '128894', 'spread': '101555', 'groupId': 'OG001'}]}]}, {'title': 'LOT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99613', 'spread': '108309', 'groupId': 'OG000'}, {'value': '78298', 'spread': '79402', 'groupId': 'OG001'}]}]}, {'title': 'LOT3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75496', 'spread': '77934', 'groupId': 'OG000'}, {'value': '88996', 'spread': '121220', 'groupId': 'OG001'}]}]}, {'title': 'LOT4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60340', 'spread': '8533', 'groupId': 'OG000'}, {'value': '39225', 'spread': '12088', 'groupId': 'OG001'}]}]}, {'title': 'LOT5-LOT7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93184', 'spread': '320836', 'groupId': 'OG000'}, {'value': '71300', 'spread': '75856', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of platelet count after start of treatment according to different treatment lines were reported.', 'unitOfMeasure': '10^3 cells per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signifies total number of participants. 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Molecular Test Performed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'KGB', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'FISH', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'RT-PCR', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'NGS', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ACGH', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with different molecular test KGB, Fluorescence in situ hybridization (FISH), Reverse transcription polymerase chain reaction (RT-PCR), Next-generation sequencing (NGS), Array Comparative Genomic Hybridization (ACGH), Other performed were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to AML Translocation Results: AML Arm Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 't(8;21)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'inv(16)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'der(11q23)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 't(6;9)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 't(1;22)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 't(7;11)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'inv(3)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 't(16;21)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'del(7q)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Monosomy 7(-7)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Complex cytogenetics/Complex karyotypes', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to different AML translocation were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Molecular Profile in Newly AML Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'ASXL1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BCOR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CEBPA', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'CSF3R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DNMT3A', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'EZH2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IDH1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'IDH2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'KIT', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'KRAS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NPM1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'NRAS', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'PTPN11', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RUNX1', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'SF3B1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SRSF2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'STAG2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TET2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'TP53', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'U2AF1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ZRSR2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLT3', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'MLL-PTD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to molecular profile were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to AML WHO Classification: AML Arm Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'AML with recurrent genetic abnormalities', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'AML with t(8;21)(q22;q22.1);RUNX1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22);CBFB', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'APL with PML', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AML with t(9;11)(p21.3;q23.3);MLLT3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AML with t(6;9)(p23;q34.1);DEK', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AML with inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AML (megakaryoblastic) with t(1;22)(p13.3;q13.3);RBM15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Provisional entity: AML with BCR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AML with mutated NPM1', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'AML with biallelic mutations of CEBPA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Provisional entity: AML with mutated RUNX1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AML with myelodysplasia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Therapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AML, NOS', 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to AML WHO classification were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'B-lymphoblastic leukemia/lymphoma, NOS', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with recurrent genetic abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2);BCR-ABL1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with t(v;11q23.3);KMT2A rearranged', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with t(12;21)(p13.2;q22.1); ETV6-RUNX1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with hyperdiploidy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with hypodiploidy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with t(5;14)(q31.1;q32.3) IL3-IGH', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'B-lymphoblastic leukemia/lymphoma with t(1;19)(q23;p13.3);TCF3-PBX1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Provisional entity: B-lymphoblastic leukemia/lymphoma, BCR-ABL1-like', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Provisional entity: B-lymphoblastic leukemia/lymphoma with iAMP21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to ALL WHO classification were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only R/R B-cell ALL participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Immunophenotyping Results for AML Arm Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'AML_IP_RES', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'cCD3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'cCD79a', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'MPO', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}]}]}, {'title': 'CD34', 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}]}]}, {'title': 'CD3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'CD4', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'CD5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'CD7', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'CD8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'TdT', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CD10', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'CD19', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'CD20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CD13', 'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}]}]}, {'title': 'CD33', 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}]}]}, {'title': 'CD14', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'CD36', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'HLADR', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}]}]}, {'title': 'glycophorin A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CD41', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CD61', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'CD117', 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Immunophenotyping Results for R/R B-cell ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'CD19', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'CD20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CD22', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'CD79a', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'HLA Dr', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'TdT', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'CD10', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'CD34', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'CD45', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Cytoplasmic IgM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only R/R B-cell ALL participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Molecular Profile in R/R B-cell ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'B-cell immunoglobulin gene rearrangement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'inv(16)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'der(11q23)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 't(6;9)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 't(4;11)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to molecular profile in R/R B-cell ALL were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only R/R B-cell ALL participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Good prognosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Intermediate prognosis', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Poor prognosis', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Undetermined prognosis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A good prognosis means that there was a high chance of recovery or healing. Intermediate prognosis was a term used to describe the likelihood of recovery or survival from a disease or condition that was neither favorable nor unfavorable. A poor prognosis refers to an estimation that there was a low chance of recovery from a disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only R/R B-cell ALL participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'title': 'Favorable', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Intermediate', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': 'Poor/Adverse', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)" under favorable (indicates a low probability or impact of adverse outcomes), intermediate (associated with moderate changes) and Poor/ Adverse (occurrence of a risk was high and the impact of the risk is severe) were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Hyper-CVAD (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'GMALL (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GRAAL (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'BFM (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Inotuzumab (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blinatumomab (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Car T-cell (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TKI inhibitor (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'FLAG (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'FLAG-IDA (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other (since de novo ALL diagnose date)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 months', 'description': 'A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL is reported. Hyper- CVAD (hyper fractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter ALL (GMALL), GRAAL, Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF). The initial diagnosis of acute leukemia could have been before 01-Jan-2015.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only R/R B-cell ALL participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time From Start of First-Line Treatment to Start of the Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '28.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Time from start of first line treatment to start of the adverse event were reported. An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Clinical Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'units': 'clinical events', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Hematological toxicities', 'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Hepatotoxicity', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal toxicities', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of clinical events were reported in this outcome measure.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clinical events', 'denomUnitsSelected': 'clinical events', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Number Analyzed' signifies events evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '508', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.7'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'EFS =time since treatment initiation until failure to achieve complete remission (CR) or disease progression (PD) after CR, or death from any cause. Participants not known to have any of these events were censored on the date they were last examined, study enrollment, last contact, whichever came later.CR=participants response to treatment according to the medical chart. AML CR =no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1\\* 10\\^9 cells/l granulocytes and more than 100\\* 10\\^9 cells/l platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia), PD=according to medical chart and accompanied by a decline in absolute neutrophil count (ANC) and platelets and increased transfusion requirement and decline in performance status or increase in symptoms.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '12.2'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'OS was defined as the time from the date of diagnosis or treatment until date of death due to any cause. If there was no death, the participants were censored at last visit or contact, whichever came later.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}]}]}, {'title': '3 years', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '35.2', 'groupId': 'OG001'}]}]}, {'title': '5 years', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Relapse Free Survival-Newly Diagnosed AML Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': "Relapse was a deterioration in health status after an improvement. Relapse free survival was considered as date of achievement of a remission until the date of relapse or death from any cause; participants not known to have relapsed or died at last follow-up were censored on the date they were last examined. CR=a participant's response to treatment according to the medical chart. Usually, AML complete remission defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1\\* 10\\^9 cells/L granulocytes and more than 100\\* 10\\^9 cells/L platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only newly AML participants were to be analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Treatment Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Complete remission-response (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response with incomplete hematological-count recovery (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission-response (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Refractory disease (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Relapsed from CR or CRi or recurrent disease (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response with incomplete hematological-count recovery (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission-response (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Refractory disease (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Relapsed from CR or CRi or recurrent disease (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response with incomplete hematological-count recovery (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission-response (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Refractory disease (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Relapsed from CR or CRi or recurrent disease (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response with incomplete hematological-count recovery (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission-response (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Refractory disease (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Relapsed from CR or CRi or recurrent disease (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission-response with incomplete hematological-count recovery (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission-response (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Refractory disease (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Relapsed from CR or CRi or recurrent disease (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (LOT5-LOT7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': "Complete remission-response (CR) defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1×109/l granulocytes and more than 100×109/l platelets in blood and no circulating leukemic blasts or evidence of extramedullary leukemia. Complete response with incomplete blood count recovery (CRi): also known as CR with incomplete hematologic recovery, participant's response to treatment according to medical chart. Partial remission: participant's response to treatment according to medical chart. All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%. Disease progression: \\>25% increase in sum of longest diameter of target lesions compared to baseline. Refractory disease: according to medical chart. No CR after 2 courses of intensive induction treatment; excluding participants with death in aplasia or death due to indeterminate cause.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. \'Number Analyzed\' signifies participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '880', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.', 'unitOfMeasure': 'Hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Reason for Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'ALL-AML Treatment', 'categories': [{'measurements': [{'value': '1064', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': 'Adverse events', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '559', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Reason for hospitalizations according to reasons such as ALL-AML treatment, adverse events were reported. One participant could have more than one reason for hospitalization.', 'unitOfMeasure': 'Hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Duration in Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean duration in intensive care unit were reported in this outcome measure.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Surgery', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Image exams', 'categories': [{'measurements': [{'value': '1187', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': 'Laboratory exams', 'categories': [{'measurements': [{'value': '1494', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}]}, {'title': 'Blood transfusions', 'categories': [{'measurements': [{'value': '1128', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'Associated treatments for infections', 'categories': [{'measurements': [{'value': '1062', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Use of mechanical ventilation', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Use of parenteral feeding', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Different clinical procedures were reported. One participant could have more than one procedure.', 'unitOfMeasure': 'Procedures', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'categories': [{'title': 'Abcess', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Catheter', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Tracheostomy', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to type of surgery were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Blood Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Platelet', 'categories': [{'measurements': [{'value': '1032', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Plasma', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cells', 'categories': [{'measurements': [{'value': '1051', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Whole blood', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.', 'unitOfMeasure': 'Blood transfusions', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'units': 'concomitant medication', 'counts': [{'value': '3343', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'OG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'classes': [{'title': 'Vancomycin', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Piperacillin; Tazobactam', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2604', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.', 'unitOfMeasure': 'Medications', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'concomitant medication', 'denomUnitsSelected': 'concomitant medication', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'FG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '518'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '518'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with newly diagnosed acute myeloid leukemia (AML) or with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) diagnosed between 01-Jan-2015 and 31-Dec-2019 were included in the study. Data was extracted from participants medical charts and was analyzed retrospectively over approximately 11 months.', 'preAssignmentDetails': 'A total of 628 participants were screened of which 39 did not meet eligibility criteria and were excluded and 589 participants were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Newly AML', 'description': 'Participants newly diagnosed with AML between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for AML were included.'}, {'id': 'BG001', 'title': 'R/R B-cell ALL', 'description': 'Participants with a confirmed diagnosis of R/R B cell ALL between 01-Jan-2015 and 31-Dec-2019 and who received at least one line of treatment for R/R B-cell ALL were included.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '16.7', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '17.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '559', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'White or Caucasian', 'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure."}], 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-20', 'size': 1133700, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-08T13:48', 'hasProtocol': True}, {'date': '2023-01-02', 'size': 825859, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-08T12:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 589}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2021-11-10', 'resultsFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-05', 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants According to Health Insurance Type', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to type of health insurance (public or private) were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Country of Residence', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.'}, {'measure': 'Number of Participants With Comorbidities', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Family History of Hematological Malignancies', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who had a family history of hematological malignancies were reported in this outcome measure.'}, {'measure': 'Number of Participants With Prior Exposure to Toxic Agents', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.'}, {'measure': 'Number of Participants With Prior Exposure to a High Dose of Radiation', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Reason for Exposure to High Dose of Radiation', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.'}, {'measure': 'Number of Participants With Bleeding History', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with bleeding history were reported in this outcome measure.'}, {'measure': 'Number of Participants With Tobacco Consumption Habits', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': "ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \\>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2, 3 and 4) was reported."}, {'measure': 'Number of Participants According to Karnofsky Performance Scores', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': "Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score was 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Score:100=normal no complaints; no disease evidence,90=able to carry normal activity; minor signs/symptoms of disease,80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry normal activity, 60=required occasional assistance, able to care for personal needs, 50=required considerable assistance \\& frequent medical care, 40=disabled; required special care/assistance,30=severely disabled; hospital admission indicated;20=very sick; hospital admission necessary,10=moribund and 0=dead."}, {'measure': 'Number of Participants According to Year of Diagnosis', 'timeFrame': 'At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Classification for Standard Newly AML Therapy', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants classified as fit or unfit for the standard newly AML therapy according to different lines of treatment (LOT) were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Drug Regimen Prescribed for Newly AML', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for newly AML were reported by each line of treatment (LOT). Drug regimen included standard 7+3, Histone deacetylases (HDACs), Low-dose Cytarabine (LDAC), FLAG (fludarabine + high-dose cytarabine + G-CSF (Granulocyte colony-stimulating factor), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Hypomethylating agents (HMA), CLAG (Cladribine + Cytarabine + G-CSF), MEC (mitoxantrone, etoposide and intermediate dose cytarabine), MICE and other.'}, {'measure': 'Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL were reported by each LOT is reported. Drug regimen included Hyper- CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter study group for ALL (GMALL), Group for Research on Adult Acute Lymphoblastic Leukemia (GRAAL), Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab, Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Other. One participant could be prescribed more than 1 drug regimen.'}, {'measure': 'Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Regimen Type in Newly AML', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to drug regimen prescribed for newly AML is reported by each LOT. Induction was the first phase of treatment. Consolidation was given after the participant had recovered from induction. Maintenance was given to maintain the remission and further prevent a relapse. Salvage was used when a disease did not respond to all other standard treatments tried.'}, {'measure': 'Treatment Duration', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'The duration of treatment according to different treatment lines were reported.'}, {'measure': 'Time to Next Treatment', 'timeFrame': 'From start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 month', 'description': 'Time to next treatment was considered as the time from the start date of the front-line therapy to the start date of a subsequent line of therapy. Participants without a subsequent line of therapy were censored at study enrollment, last visit, last contact, or death, whichever comes first.'}, {'measure': 'Total Number of Cycles', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Total number of cycles according to each line of treatment is reported in this outcome measure.'}, {'measure': 'Number of Participants Who Withdrew Regimen', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Reasons for Withdrawing Regimen', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to reasons such as progression of the disease, Adverse event toxicity, participants refusal to continue the treatment scheme, cost related or access barriers and other for withdrawing regimen according to each line of treatment were reported in this outcome measure. One participant could have more than one reason for withdrawing regimen.'}, {'measure': 'Number of Participants With Dose Reduction', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.'}, {'measure': 'Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression', 'timeFrame': 'At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.'}, {'measure': 'Duration of Radiotherapy', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.'}, {'measure': 'Dose of Radiotherapy', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Location of Application of Radiotherapy', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Intrathecal Chemotherapy', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to intrathecal chemotherapy such as methotrexate, cytarabine, prednisone, dexamethasone, other according to each line of treatment is reported in this outcome measure. One participant may receive more than one intrathecal chemotherapy.'}, {'measure': 'Number of Participants With Stem Cell Transplant (SCT)', 'timeFrame': 'From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with stem cell transplant were reported in this outcome measure.'}, {'measure': 'Absolute Value of Hemoglobin Before Treatment Line', 'timeFrame': 'Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of Hemoglobin After Start of Treatment Line', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of White Blood Cell Count Before Treatment Line', 'timeFrame': 'Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of White Blood Cell Count After Start of Treatment Line', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Neutrophil Count (ANC) Before Treatment Line', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Neutrophil Count (ANC) After Start of Treatment Line', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of Blast Count Before Treatment Line', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of Blast Count After Start of Treatment Line', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of Platelets Count Before Treatment Line', 'timeFrame': 'Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.'}, {'measure': 'Absolute Value of Platelets Count After Start of Treatment Line', 'timeFrame': 'After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Absolute value of platelet count after start of treatment according to different treatment lines were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Molecular Test Performed', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants with different molecular test KGB, Fluorescence in situ hybridization (FISH), Reverse transcription polymerase chain reaction (RT-PCR), Next-generation sequencing (NGS), Array Comparative Genomic Hybridization (ACGH), Other performed were reported.'}, {'measure': 'Number of Participants According to AML Translocation Results: AML Arm Only', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to different AML translocation were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Molecular Profile in Newly AML Arm', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to molecular profile were reported in this outcome measure.'}, {'measure': 'Number of Participants According to AML WHO Classification: AML Arm Only', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to AML WHO classification were reported in this outcome measure.'}, {'measure': 'Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to ALL WHO classification were reported in this outcome measure.'}, {'measure': 'Number of Participants According to Immunophenotyping Results for AML Arm Only', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.'}, {'measure': 'Number of Participants According to Immunophenotyping Results for R/R B-cell ALL', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.'}, {'measure': 'Number of Participants According to Molecular Profile in R/R B-cell ALL', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to molecular profile in R/R B-cell ALL were reported.'}, {'measure': 'Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only', 'timeFrame': 'At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'A good prognosis means that there was a high chance of recovery or healing. Intermediate prognosis was a term used to describe the likelihood of recovery or survival from a disease or condition that was neither favorable nor unfavorable. A poor prognosis refers to an estimation that there was a low chance of recovery from a disease.'}, {'measure': 'Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)', 'timeFrame': 'From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)" under favorable (indicates a low probability or impact of adverse outcomes), intermediate (associated with moderate changes) and Poor/ Adverse (occurrence of a risk was high and the impact of the risk is severe) were reported.'}, {'measure': 'Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL', 'timeFrame': 'From the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 months', 'description': 'A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL is reported. Hyper- CVAD (hyper fractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter ALL (GMALL), GRAAL, Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF). The initial diagnosis of acute leukemia could have been before 01-Jan-2015.'}, {'measure': 'Time From Start of First-Line Treatment to Start of the Adverse Event', 'timeFrame': 'From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Time from start of first line treatment to start of the adverse event were reported. An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Clinical Events', 'timeFrame': 'From diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of clinical events were reported in this outcome measure.'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'EFS =time since treatment initiation until failure to achieve complete remission (CR) or disease progression (PD) after CR, or death from any cause. Participants not known to have any of these events were censored on the date they were last examined, study enrollment, last contact, whichever came later.CR=participants response to treatment according to the medical chart. AML CR =no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1\\* 10\\^9 cells/l granulocytes and more than 100\\* 10\\^9 cells/l platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia), PD=according to medical chart and accompanied by a decline in absolute neutrophil count (ANC) and platelets and increased transfusion requirement and decline in performance status or increase in symptoms.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'OS was defined as the time from the date of diagnosis or treatment until date of death due to any cause. If there was no death, the participants were censored at last visit or contact, whichever came later.'}, {'measure': 'Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation', 'timeFrame': '1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months', 'description': 'Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.'}, {'measure': 'Relapse Free Survival-Newly Diagnosed AML Participants Only', 'timeFrame': 'From date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': "Relapse was a deterioration in health status after an improvement. Relapse free survival was considered as date of achievement of a remission until the date of relapse or death from any cause; participants not known to have relapsed or died at last follow-up were censored on the date they were last examined. CR=a participant's response to treatment according to the medical chart. Usually, AML complete remission defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1\\* 10\\^9 cells/L granulocytes and more than 100\\* 10\\^9 cells/L platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia."}, {'measure': 'Number of Participants According to Treatment Response', 'timeFrame': 'From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': "Complete remission-response (CR) defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \\<5% bone marrow blasts and more than 1×109/l granulocytes and more than 100×109/l platelets in blood and no circulating leukemic blasts or evidence of extramedullary leukemia. Complete response with incomplete blood count recovery (CRi): also known as CR with incomplete hematologic recovery, participant's response to treatment according to medical chart. Partial remission: participant's response to treatment according to medical chart. All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%. Disease progression: \\>25% increase in sum of longest diameter of target lesions compared to baseline. Refractory disease: according to medical chart. No CR after 2 courses of intensive induction treatment; excluding participants with death in aplasia or death due to indeterminate cause."}, {'measure': 'Number of Hospitalizations', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.'}, {'measure': 'Reason for Hospitalization', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Reason for hospitalizations according to reasons such as ALL-AML treatment, adverse events were reported. One participant could have more than one reason for hospitalization.'}, {'measure': 'Duration in Intensive Care Unit', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Mean duration in intensive care unit were reported in this outcome measure.'}, {'measure': 'Number of Procedures', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Different clinical procedures were reported. One participant could have more than one procedure.'}, {'measure': 'Number of Participants According to Surgery', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number of participants according to type of surgery were reported in this outcome measure.'}, {'measure': 'Number of Blood Transfusions', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.'}, {'measure': 'Number of Concomitant Medications', 'timeFrame': 'From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months', 'description': 'Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'Acute Lymphoid Leukemia', 'Relapsed Refractory B-cell Acute Lymphoblastic Leukemia', 'Acute Leukemia in Latin America', 'LOYAL study'], 'conditions': ['Acute Myeloid Leukemia', 'Acute Lymphoid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=X9001302', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.', 'detailedDescription': 'This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients ≥18 years old at diagnosis, with de novo AML or R/R B-cell ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML or R/R ALL within the study period.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 years old at diagnosis\n* Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019\n* At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period\n\nExclusion Criteria:\n\n* Patients with no medical chart available\n* Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)\n* Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment\n* Patients with secondary AML\n* Patients with any concomitant primary malignancy\n* Patients with acute promyelocytic leukemia (APL)"}, 'identificationModule': {'nctId': 'NCT05166135', 'acronym': 'LOYAL', 'briefTitle': 'Latin American Real-world Study in Acute Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study', 'orgStudyIdInfo': {'id': 'X9001302'}, 'secondaryIdInfos': [{'id': 'LOYAL', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Myeloid Leukemia', 'description': "Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period."}, {'label': 'Relapsed/Refractory Acute Lymphoid Leukemia', 'description': "Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1900AXI', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de La Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B1629ODT', 'city': 'Pilar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': '1114', 'city': 'Buenos Aires', 'state': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'FUNDALEU - Fundacion para combatir la Leucemia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5016', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Privado Centro Medico de Cordoba S.A.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5000JHQ', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Sanatorio Allende', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '41253-190', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital São Rafael', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '17210-120', 'city': 'Jaú', 'state': 'SAO Paulo / Brazil', 'country': 'Brazil', 'facility': 'Fundação Doutor Amaral Carvalho', 'geoPoint': {'lat': -22.29639, 'lon': -48.55778}}, {'zip': '22793-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto COI de Pesquisa', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01246-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01323-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Beneficência Portuguesa de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05652000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4070038', 'city': 'Concepción', 'country': 'Chile', 'facility': 'Hospital Guillermo Grant Benavente', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'zip': '111071', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Fundacion Santa Fe de Bogota', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '230002', 'city': 'Montería', 'country': 'Colombia', 'facility': 'Oncomedica SA', 'geoPoint': {'lat': 8.75081, 'lon': -75.87823}}], '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'}}}}