Acute Lymphoid Leukemia, Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Relapsed Refractory B-cell Acute Lymphoblastic Leukemia, Acute Leukemia in Latin America, LOYAL study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old at diagnosis * Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019 * At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period
Exclusion criteria
* Patients with no medical chart available * Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data) * Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment * Patients with secondary AML * Patients with any concomitant primary malignancy * Patients with acute promyelocytic leukemia (APL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Value of Platelets Count After Start of Treatment Line | 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 | Absolute value of platelet count after start of treatment according to different treatment lines were reported. |
| Number of Participants According to Drug Regimen Prescribed for Newly AML | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure. |
| Number of Participants According to Regimen Type in Newly AML | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Treatment Duration | 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 | The duration of treatment according to different treatment lines were reported. |
| Time to Next Treatment | 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 | 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. |
| Total Number of Cycles | 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 | Total number of cycles according to each line of treatment is reported in this outcome measure. |
| Number of Participants Who Withdrew Regimen | 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 | Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure. |
| Number of Participants According to Reasons for Withdrawing Regimen | 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 | 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. |
| Number of Participants With Dose Reduction | 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 | Number of participants with dose reduction according to each line of treatment were reported in this outcome measure. |
| Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure. |
| Duration of Radiotherapy | 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 | Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure. |
| Dose of Radiotherapy | 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 | Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure. |
| Number of Participants According to Location of Application of Radiotherapy | 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 | Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure. |
| Number of Participants According to Intrathecal Chemotherapy | 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 | 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. |
| Number of Participants With Stem Cell Transplant (SCT) | 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 | Number of participants with stem cell transplant were reported in this outcome measure. |
| Absolute Value of Hemoglobin Before Treatment Line | 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 | Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of Hemoglobin After Start of Treatment Line | 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 | Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of White Blood Cell Count Before Treatment Line | 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 | Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of White Blood Cell Count After Start of Treatment Line | 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 | Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Neutrophil Count (ANC) Before Treatment Line | Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months | Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Neutrophil Count (ANC) After Start of Treatment Line | 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 | Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of Blast Count Before Treatment Line | Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months | Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of Blast Count After Start of Treatment Line | 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 | Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure. |
| Absolute Value of Platelets Count Before Treatment Line | Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months | Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure. |
| Number of Participants According to Health Insurance Type | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants according to type of health insurance (public or private) were reported in this outcome measure. |
| Number of Participants According to Country of Residence | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure. |
| Number of Participants With Comorbidities | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure. |
| Number of Participants According to Family History of Hematological Malignancies | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants who had a family history of hematological malignancies were reported in this outcome measure. |
| Number of Participants With Prior Exposure to Toxic Agents | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants who had any prior exposure to toxic agents were reported in this outcome measure. |
| Number of Participants With Prior Exposure to a High Dose of Radiation | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure. |
| Number of Participants According to Reason for Exposure to High Dose of Radiation | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure. |
| Number of Participants With Bleeding History | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants with bleeding history were reported in this outcome measure. |
| Number of Participants With Tobacco Consumption Habits | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure. |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants According to Karnofsky Performance Scores | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants According to Year of Diagnosis | At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months | Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure. |
| Number of Participants According to Classification for Standard Newly AML Therapy | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to AML Translocation Results: AML Arm Only | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months | Number of participants according to different AML translocation were reported in this outcome measure. |
| Number of Participants According to Molecular Profile in Newly AML Arm | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months | Number of participants according to molecular profile were reported in this outcome measure. |
| Number of Participants According to AML WHO Classification: AML Arm Only | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants according to AML WHO classification were reported in this outcome measure. |
| Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants according to ALL WHO classification were reported in this outcome measure. |
| Number of Participants According to Immunophenotyping Results for AML Arm Only | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure. |
| Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure. |
| Number of Participants According to Molecular Profile in R/R B-cell ALL | At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | Number of participants according to molecular profile in R/R B-cell ALL were reported. |
| Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only | At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN) | From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | 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 | 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. |
| Time From Start of First-Line Treatment to Start of the Adverse Event | From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
| Number of Clinical Events | 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 | Number of clinical events were reported in this outcome measure. |
| Event Free Survival (EFS) | 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 | 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. |
| Overall Survival (OS) | 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 | 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. |
| Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months | Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure. |
| Relapse Free Survival-Newly Diagnosed AML Participants Only | 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 | 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. |
| Number of Participants According to Treatment Response | 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 | 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. |
| Number of Hospitalizations | 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 | Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization. |
| Reason for Hospitalization | 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 | 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. |
| Duration in Intensive Care Unit | 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 | Mean duration in intensive care unit were reported in this outcome measure. |
| Number of Procedures | 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 | Different clinical procedures were reported. One participant could have more than one procedure. |
| Number of Participants According to Surgery | 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 | Number of participants according to type of surgery were reported in this outcome measure. |
| Number of Blood Transfusions | 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 | Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions. |
| Number of Concomitant Medications | 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 | Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events. |
| Number of Participants With Molecular Test Performed | At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months | 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. |
Countries
Argentina, Brazil, Chile, Colombia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Newly AML 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. | 518 |
| R/R B-cell ALL 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. | 71 |
| Total | 589 |
Baseline characteristics
| Characteristic | R/R B-cell ALL | Total | Newly AML |
|---|---|---|---|
| Age, Continuous | 36.6 Years STANDARD_DEVIATION 15.5 | 52.5 Years STANDARD_DEVIATION 17.6 | 54.7 Years STANDARD_DEVIATION 16.7 |
| Race/Ethnicity, Customized American Indian | 9 Participants | 47 Participants | 38 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 25 Participants | 21 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 89 Participants | 69 Participants |
| Race/Ethnicity, Customized White or Caucasian | 33 Participants | 396 Participants | 363 Participants |
| Sex: Female, Male Female | 31 Participants | 295 Participants | 264 Participants |
| Sex: Female, Male Male | 40 Participants | 294 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 392 / 518 | 60 / 71 |
| other Total, other adverse events | 2 / 518 | 1 / 71 |
| serious Total, serious adverse events | 2 / 518 | 0 / 71 |
Outcome results
Primary
Absolute Neutrophil Count (ANC) After Start of Treatment Line
Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT2 | 4.9 10^9cells per Liter | Standard Deviation 13.9 |
| Newly AML | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT4 | 12.4 10^9cells per Liter | Standard Deviation 28.2 |
| Newly AML | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT3 | 7.4 10^9cells per Liter | Standard Deviation 19.4 |
| Newly AML | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT5-LOT7 | 18.5 10^9cells per Liter | Standard Deviation 32.4 |
| Newly AML | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT1 | 4.1 10^9cells per Liter | Standard Deviation 10.5 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT5-LOT7 | 2.1 10^9cells per Liter | Standard Deviation 2.2 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT1 | 6.8 10^9cells per Liter | Standard Deviation 18.7 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT2 | 4.4 10^9cells per Liter | Standard Deviation 9.7 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT3 | 1.9 10^9cells per Liter | Standard Deviation 2.8 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) After Start of Treatment Line | LOT4 | 13.9 10^9cells per Liter | Standard Deviation 27.5 |
Primary
Absolute Neutrophil Count (ANC) Before Treatment Line
Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT2 | 6.3 10^9cells per Liter | Standard Deviation 13.7 |
| Newly AML | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT4 | 11.0 10^9cells per Liter | Standard Deviation 23.8 |
| Newly AML | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT3 | 8.8 10^9cells per Liter | Standard Deviation 20.1 |
| Newly AML | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT5-LOT7 | 15.1 10^9cells per Liter | Standard Deviation 31.4 |
| Newly AML | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT1 | 5.0 10^9cells per Liter | Standard Deviation 21 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT5-LOT7 | 3.7 10^9cells per Liter | Standard Deviation 2.3 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT1 | 4.5 10^9cells per Liter | Standard Deviation 6.5 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT2 | 5.7 10^9cells per Liter | Standard Deviation 9.3 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT3 | 2.1 10^9cells per Liter | Standard Deviation 2 |
| R/R B-cell ALL | Absolute Neutrophil Count (ANC) Before Treatment Line | LOT4 | 1.9 10^9cells per Liter | Standard Deviation 2.1 |
Primary
Absolute Value of Blast Count After Start of Treatment Line
Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Blast Count After Start of Treatment Line | LOT2 | 6.9 Percentage of blast cells | Standard Deviation 19 |
| Newly AML | Absolute Value of Blast Count After Start of Treatment Line | LOT4 | 9.2 Percentage of blast cells | Standard Deviation 22.4 |
| Newly AML | Absolute Value of Blast Count After Start of Treatment Line | LOT3 | 7.6 Percentage of blast cells | Standard Deviation 21.9 |
| Newly AML | Absolute Value of Blast Count After Start of Treatment Line | LOT5-LOT7 | 13.0 Percentage of blast cells | Standard Deviation 23 |
| Newly AML | Absolute Value of Blast Count After Start of Treatment Line | LOT1 | 7.7 Percentage of blast cells | Standard Deviation 19.8 |
| R/R B-cell ALL | Absolute Value of Blast Count After Start of Treatment Line | LOT5-LOT7 | 0 Percentage of blast cells | Standard Deviation 0 |
| R/R B-cell ALL | Absolute Value of Blast Count After Start of Treatment Line | LOT1 | 7.2 Percentage of blast cells | Standard Deviation 20.8 |
| R/R B-cell ALL | Absolute Value of Blast Count After Start of Treatment Line | LOT2 | 11.9 Percentage of blast cells | Standard Deviation 28.5 |
| R/R B-cell ALL | Absolute Value of Blast Count After Start of Treatment Line | LOT3 | 13.6 Percentage of blast cells | Standard Deviation 29.1 |
| R/R B-cell ALL | Absolute Value of Blast Count After Start of Treatment Line | LOT4 | 0.7 Percentage of blast cells | Standard Deviation 2 |
Primary
Absolute Value of Blast Count Before Treatment Line
Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Blast Count Before Treatment Line | LOT2 | 12.0 Percentage of blast cells | Standard Deviation 26.1 |
| Newly AML | Absolute Value of Blast Count Before Treatment Line | LOT4 | 11.2 Percentage of blast cells | Standard Deviation 25.8 |
| Newly AML | Absolute Value of Blast Count Before Treatment Line | LOT3 | 22.4 Percentage of blast cells | Standard Deviation 35.8 |
| Newly AML | Absolute Value of Blast Count Before Treatment Line | LOT5-LOT7 | 30.8 Percentage of blast cells | Standard Deviation 35.2 |
| Newly AML | Absolute Value of Blast Count Before Treatment Line | LOT1 | 37.5 Percentage of blast cells | Standard Deviation 33.4 |
| R/R B-cell ALL | Absolute Value of Blast Count Before Treatment Line | LOT5-LOT7 | 14.7 Percentage of blast cells | Standard Deviation 35.9 |
| R/R B-cell ALL | Absolute Value of Blast Count Before Treatment Line | LOT1 | 36.4 Percentage of blast cells | Standard Deviation 35 |
| R/R B-cell ALL | Absolute Value of Blast Count Before Treatment Line | LOT2 | 16.9 Percentage of blast cells | Standard Deviation 30 |
| R/R B-cell ALL | Absolute Value of Blast Count Before Treatment Line | LOT3 | 20.4 Percentage of blast cells | Standard Deviation 30.5 |
| R/R B-cell ALL | Absolute Value of Blast Count Before Treatment Line | LOT4 | 12.7 Percentage of blast cells | Standard Deviation 27.7 |
Primary
Absolute Value of Hemoglobin After Start of Treatment Line
Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Hemoglobin After Start of Treatment Line | LOT2 | 8.7 Grams per deciliter | Standard Deviation 1.6 |
| Newly AML | Absolute Value of Hemoglobin After Start of Treatment Line | LOT4 | 8.6 Grams per deciliter | Standard Deviation 1.4 |
| Newly AML | Absolute Value of Hemoglobin After Start of Treatment Line | LOT3 | 8.9 Grams per deciliter | Standard Deviation 2.1 |
| Newly AML | Absolute Value of Hemoglobin After Start of Treatment Line | LOT5-LOT7 | 8.7 Grams per deciliter | Standard Deviation 1.6 |
| Newly AML | Absolute Value of Hemoglobin After Start of Treatment Line | LOT1 | 8.3 Grams per deciliter | Standard Deviation 1.6 |
| R/R B-cell ALL | Absolute Value of Hemoglobin After Start of Treatment Line | LOT5-LOT7 | 9.2 Grams per deciliter | Standard Deviation 2 |
| R/R B-cell ALL | Absolute Value of Hemoglobin After Start of Treatment Line | LOT1 | 10.0 Grams per deciliter | Standard Deviation 2.2 |
| R/R B-cell ALL | Absolute Value of Hemoglobin After Start of Treatment Line | LOT2 | 9.3 Grams per deciliter | Standard Deviation 2.3 |
| R/R B-cell ALL | Absolute Value of Hemoglobin After Start of Treatment Line | LOT3 | 9.5 Grams per deciliter | Standard Deviation 2.3 |
| R/R B-cell ALL | Absolute Value of Hemoglobin After Start of Treatment Line | LOT4 | 8.5 Grams per deciliter | Standard Deviation 1.7 |
Primary
Absolute Value of Hemoglobin Before Treatment Line
Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Hemoglobin Before Treatment Line | LOT2 | 9.2 Grams per deciliter | Standard Deviation 1.8 |
| Newly AML | Absolute Value of Hemoglobin Before Treatment Line | LOT4 | 9.2 Grams per deciliter | Standard Deviation 1.5 |
| Newly AML | Absolute Value of Hemoglobin Before Treatment Line | LOT3 | 9.3 Grams per deciliter | Standard Deviation 2.1 |
| Newly AML | Absolute Value of Hemoglobin Before Treatment Line | LOT5-LOT7 | 9.5 Grams per deciliter | Standard Deviation 2.2 |
| Newly AML | Absolute Value of Hemoglobin Before Treatment Line | LOT1 | 8.3 Grams per deciliter | Standard Deviation 1.7 |
| R/R B-cell ALL | Absolute Value of Hemoglobin Before Treatment Line | LOT5-LOT7 | 9.9 Grams per deciliter | Standard Deviation 1.7 |
| R/R B-cell ALL | Absolute Value of Hemoglobin Before Treatment Line | LOT1 | 9.2 Grams per deciliter | Standard Deviation 2.2 |
| R/R B-cell ALL | Absolute Value of Hemoglobin Before Treatment Line | LOT2 | 10.4 Grams per deciliter | Standard Deviation 2.2 |
| R/R B-cell ALL | Absolute Value of Hemoglobin Before Treatment Line | LOT3 | 9.9 Grams per deciliter | Standard Deviation 2.3 |
| R/R B-cell ALL | Absolute Value of Hemoglobin Before Treatment Line | LOT4 | 9.4 Grams per deciliter | Standard Deviation 2.2 |
Primary
Absolute Value of Platelets Count After Start of Treatment Line
Absolute value of platelet count after start of treatment according to different treatment lines were reported.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Platelets Count After Start of Treatment Line | LOT2 | 99613 10^3 cells per microliter | Standard Deviation 108309 |
| Newly AML | Absolute Value of Platelets Count After Start of Treatment Line | LOT4 | 60340 10^3 cells per microliter | Standard Deviation 8533 |
| Newly AML | Absolute Value of Platelets Count After Start of Treatment Line | LOT3 | 75496 10^3 cells per microliter | Standard Deviation 77934 |
| Newly AML | Absolute Value of Platelets Count After Start of Treatment Line | LOT5-LOT7 | 93184 10^3 cells per microliter | Standard Deviation 320836 |
| Newly AML | Absolute Value of Platelets Count After Start of Treatment Line | LOT1 | 105713 10^3 cells per microliter | Standard Deviation 153196 |
| R/R B-cell ALL | Absolute Value of Platelets Count After Start of Treatment Line | LOT5-LOT7 | 71300 10^3 cells per microliter | Standard Deviation 75856 |
| R/R B-cell ALL | Absolute Value of Platelets Count After Start of Treatment Line | LOT1 | 128894 10^3 cells per microliter | Standard Deviation 101555 |
| R/R B-cell ALL | Absolute Value of Platelets Count After Start of Treatment Line | LOT2 | 78298 10^3 cells per microliter | Standard Deviation 79402 |
| R/R B-cell ALL | Absolute Value of Platelets Count After Start of Treatment Line | LOT3 | 88996 10^3 cells per microliter | Standard Deviation 121220 |
| R/R B-cell ALL | Absolute Value of Platelets Count After Start of Treatment Line | LOT4 | 39225 10^3 cells per microliter | Standard Deviation 12088 |
Primary
Absolute Value of Platelets Count Before Treatment Line
Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of Platelets Count Before Treatment Line | LOT3 | 112035 10^3 cells per microliter | Standard Deviation 120858 |
| Newly AML | Absolute Value of Platelets Count Before Treatment Line | LOT2 | 153362 10^3 cells per microliter | Standard Deviation 141776 |
| Newly AML | Absolute Value of Platelets Count Before Treatment Line | LOT4 | 143263 10^3 cells per microliter | Standard Deviation 122895 |
| Newly AML | Absolute Value of Platelets Count Before Treatment Line | LOT5-LOT7 | 101231 10^3 cells per microliter | Standard Deviation 113248 |
| Newly AML | Absolute Value of Platelets Count Before Treatment Line | LOT1 | 68613 10^3 cells per microliter | Standard Deviation 75931 |
| R/R B-cell ALL | Absolute Value of Platelets Count Before Treatment Line | LOT5-LOT7 | 77200 10^3 cells per microliter | Standard Deviation 60318 |
| R/R B-cell ALL | Absolute Value of Platelets Count Before Treatment Line | LOT1 | 69220 10^3 cells per microliter | Standard Deviation 80225 |
| R/R B-cell ALL | Absolute Value of Platelets Count Before Treatment Line | LOT2 | 115181 10^3 cells per microliter | Standard Deviation 110273 |
| R/R B-cell ALL | Absolute Value of Platelets Count Before Treatment Line | LOT3 | 91565 10^3 cells per microliter | Standard Deviation 95696 |
| R/R B-cell ALL | Absolute Value of Platelets Count Before Treatment Line | LOT4 | 69100 10^3 cells per microliter | Standard Deviation 96956 |
Primary
Absolute Value of White Blood Cell Count After Start of Treatment Line
Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT2 | 6.7 10^9cells per Liter | Standard Deviation 18.3 |
| Newly AML | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT4 | 12.0 10^9cells per Liter | Standard Deviation 40.7 |
| Newly AML | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT3 | 16.3 10^9cells per Liter | Standard Deviation 70.2 |
| Newly AML | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT5-LOT7 | 6.8 10^9cells per Liter | Standard Deviation 13 |
| Newly AML | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT1 | 7.8 10^9cells per Liter | Standard Deviation 20.4 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT5-LOT7 | 3.1 10^9cells per Liter | Standard Deviation 2.3 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT1 | 6.4 10^9cells per Liter | Standard Deviation 6.7 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT2 | 10.7 10^9cells per Liter | Standard Deviation 32.4 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT3 | 7.9 10^9cells per Liter | Standard Deviation 18.2 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count After Start of Treatment Line | LOT4 | 4.9 10^9cells per Liter | Standard Deviation 9.3 |
Primary
Absolute Value of White Blood Cell Count Before Treatment Line
Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Absolute Value of White Blood Cell Count Before Treatment Line | LOT2 | 12.6 10^9cells per Liter | Standard Deviation 33.6 |
| Newly AML | Absolute Value of White Blood Cell Count Before Treatment Line | LOT4 | 7.9 10^9cells per Liter | Standard Deviation 13.7 |
| Newly AML | Absolute Value of White Blood Cell Count Before Treatment Line | LOT3 | 17.4 10^9cells per Liter | Standard Deviation 34 |
| Newly AML | Absolute Value of White Blood Cell Count Before Treatment Line | LOT5-LOT7 | 15.7 10^9cells per Liter | Standard Deviation 39.3 |
| Newly AML | Absolute Value of White Blood Cell Count Before Treatment Line | LOT1 | 41.7 10^9cells per Liter | Standard Deviation 168.6 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count Before Treatment Line | LOT5-LOT7 | 17.0 10^9cells per Liter | Standard Deviation 29.8 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count Before Treatment Line | LOT1 | 35.7 10^9cells per Liter | Standard Deviation 58.1 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count Before Treatment Line | LOT2 | 26.8 10^9cells per Liter | Standard Deviation 48.4 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count Before Treatment Line | LOT3 | 26.4 10^9cells per Liter | Standard Deviation 58.6 |
| R/R B-cell ALL | Absolute Value of White Blood Cell Count Before Treatment Line | LOT4 | 32.4 10^9cells per Liter | Standard Deviation 69.3 |
Primary
Dose of Radiotherapy
Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Dose of Radiotherapy | LOT1 | 300 Rad | — |
| Newly AML | Dose of Radiotherapy | LOT2 | 25 Rad | — |
| Newly AML | Dose of Radiotherapy | LOT3 | 2400 Rad | — |
| R/R B-cell ALL | Dose of Radiotherapy | LOT1 | 2267 Rad | Standard Deviation 1553 |
| R/R B-cell ALL | Dose of Radiotherapy | LOT3 | 24 Rad | — |
Primary
Duration of Radiotherapy
Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Duration of Radiotherapy | LOT1 | 0.3 Months | Standard Deviation 0 |
| Newly AML | Duration of Radiotherapy | LOT3 | 0.5 Months | — |
| R/R B-cell ALL | Duration of Radiotherapy | LOT1 | 0.7 Months | Standard Deviation 0.6 |
Primary
Number of Participants According to Classification for Standard Newly AML Therapy
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.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT1 | Fit | 390 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT1 | Unfit | 99 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT2 | Fit | 217 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT2 | Unfit | 43 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT3 | Fit | 102 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT3 | Unfit | 32 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT4 | Fit | 40 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT4 | Unfit | 13 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT5-LOT7 | Fit | 15 Participants |
| Newly AML | Number of Participants According to Classification for Standard Newly AML Therapy | LOT5-LOT7 | Unfit | 10 Participants |
Primary
Number of Participants According to Country of Residence
Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Country of Residence | Argentina | 166 Participants |
| Newly AML | Number of Participants According to Country of Residence | Brazil | 205 Participants |
| Newly AML | Number of Participants According to Country of Residence | Chile | 63 Participants |
| Newly AML | Number of Participants According to Country of Residence | Colombia | 84 Participants |
| R/R B-cell ALL | Number of Participants According to Country of Residence | Colombia | 21 Participants |
| R/R B-cell ALL | Number of Participants According to Country of Residence | Argentina | 23 Participants |
| R/R B-cell ALL | Number of Participants According to Country of Residence | Chile | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Country of Residence | Brazil | 27 Participants |
Primary
Number of Participants According to Drug Regimen Prescribed for Newly AML
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.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Standard 7+3 (LOT1) | 390 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HDAC (LOT1) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | LDAC (LOT1) | 25 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG (LOT1) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG-IDA (LOT1) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HMA (LOT1) | 47 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | CLAG (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MEC (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MICE (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Other (LOT1) | 47 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Standard 7+3 (LOT2) | 9 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HDAC (LOT2) | 85 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | LDAC (LOT2) | 7 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG (LOT2) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG-IDA (LOT2) | 66 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HMA (LOT2) | 26 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | CLAG (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MEC (LOT2) | 24 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MICE (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Other (LOT2) | 56 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Standard 7+3 (LOT3) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HDAC (LOT3) | 24 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | LDAC (LOT3) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG (LOT3) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG-IDA (LOT3) | 36 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HMA (LOT3) | 30 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | CLAG (LOT3) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MEC (LOT3) | 9 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MICE (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Other (LOT3) | 31 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Standard 7+3 (LOT4) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HDAC (LOT4) | 20 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | LDAC (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG-IDA (LOT4) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HMA (LOT4) | 13 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | CLAG (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MEC (LOT4) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MICE (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Other (LOT4) | 14 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Standard 7+3 (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HDAC (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | LDAC (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | FLAG-IDA (LOT5-LOT7) | 7 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | HMA (LOT5-LOT7) | 4 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | CLAG (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MEC (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | MICE (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for Newly AML | Other (LOT5-LOT7) | 10 Participants |
Primary
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
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.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Hyper-CVAD (LOT1) | 16 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GMALL (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GRAAL (LOT1) | 11 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | BFM (LOT1) | 15 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Inotuzumab (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Blinatumomab (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Car T-cell (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | TKI inhibitor (LOT1) | 4 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG (LOT1) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG-IDA (LOT1) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Other (LOT1) | 29 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Hyper-CVAD (LOT2) | 14 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GMALL (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GRAAL (LOT2) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | BFM (LOT2) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Inotuzumab (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Blinatumomab (LOT2) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Car T-cell (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | TKI inhibitor (LOT2) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG (LOT2) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG-IDA (LOT2) | 15 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Other (LOT2) | 22 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Hyper-CVAD (LOT3) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GMALL (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GRAAL (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | BFM (LOT3) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Inotuzumab (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Blinatumomab (LOT3) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Car T-cell (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | TKI inhibitor (LOT3) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG-IDA (LOT3) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Other (LOT3) | 12 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Hyper-CVAD (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GMALL (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GRAAL (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | BFM (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Inotuzumab (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Blinatumomab (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Car T-cell (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | TKI inhibitor (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG-IDA (LOT4) | 3 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Other (LOT4) | 7 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Hyper-CVAD (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GMALL (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | GRAAL (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | BFM (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Inotuzumab (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Blinatumomab (LOT5-LOT7) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Car T-cell (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | TKI inhibitor (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | FLAG-IDA (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL | Other (LOT5-LOT7) | 4 Participants |
Primary
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
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.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 1 | 185 Participants |
| Newly AML | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 3 | 16 Participants |
| Newly AML | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 0 | 136 Participants |
| Newly AML | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 4 | 5 Participants |
| Newly AML | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 2 | 45 Participants |
| R/R B-cell ALL | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 4 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 0 | 29 Participants |
| R/R B-cell ALL | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 1 | 21 Participants |
| R/R B-cell ALL | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 2 | 7 Participants |
| R/R B-cell ALL | Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores | 3 | 0 Participants |
Primary
Number of Participants According to Family History of Hematological Malignancies
Number of participants who had a family history of hematological malignancies were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants According to Family History of Hematological Malignancies | 21 Participants |
| R/R B-cell ALL | Number of Participants According to Family History of Hematological Malignancies | 3 Participants |
Primary
Number of Participants According to Health Insurance Type
Number of participants according to type of health insurance (public or private) were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Health Insurance Type | Private | 265 Participants |
| Newly AML | Number of Participants According to Health Insurance Type | Public | 253 Participants |
| R/R B-cell ALL | Number of Participants According to Health Insurance Type | Private | 44 Participants |
| R/R B-cell ALL | Number of Participants According to Health Insurance Type | Public | 27 Participants |
Primary
Number of Participants According to Intrathecal Chemotherapy
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT2) | 18 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT1) | 75 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT3) | 8 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT2) | 33 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Other (LOT3) | 1 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT1) | 70 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT4) | 6 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT4) | 5 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT1) | 74 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT4) | 6 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT2) | 32 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Other (LOT1) | 5 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Other (LOT2) | 4 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Other (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT1) | 42 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT3) | 10 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT2) | 35 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT3) | 6 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT3) | 9 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Other (LOT5-LOT7) | 1 Participants |
| Newly AML | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Other (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT1) | 49 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT1) | 46 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT1) | 44 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT1) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT1) | 41 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Other (LOT1) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT2) | 29 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT2) | 28 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT2) | 24 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT2) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT2) | 25 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Other (LOT2) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT3) | 10 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT3) | 10 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT3) | 8 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT3) | 9 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Other (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT4) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT4) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT4) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT4) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Other (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Intrathecal chemotherapy (LOT5-LOT7) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Methotrexate (LOT5-LOT7) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Cytarabine (LOT5-LOT7) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Prednisone (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Intrathecal Chemotherapy | Dexamethasone (LOT5-LOT7) | 2 Participants |
Primary
Number of Participants According to Karnofsky Performance Scores
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.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 100 | 110 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 90 | 107 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 80 | 69 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 70 | 29 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 60 | 4 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 50 | 14 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 40 | 4 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 30 | 0 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 20 | 0 Participants |
| Newly AML | Number of Participants According to Karnofsky Performance Scores | 10 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 30 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 100 | 27 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 50 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 90 | 12 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 10 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 80 | 7 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 40 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 70 | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 20 | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Karnofsky Performance Scores | 60 | 2 Participants |
Primary
Number of Participants According to Location of Application of Radiotherapy
Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT3 | Other | 1 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT1 | CNS (cranial irradiation) | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT1 | Total body irradiation | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT1 | Other | 1 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT2 | CNS (cranial irradiation) | 1 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT2 | Total body irradiation | 1 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT2 | Other | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT3 | CNS (cranial irradiation) | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT3 | Total body irradiation | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT4 | CNS (cranial irradiation) | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT4 | Total body irradiation | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT4 | Other | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | CNS (cranial irradiation) | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | Total body irradiation | 0 Participants |
| Newly AML | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT4 | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT3 | Total body irradiation | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT1 | CNS (cranial irradiation) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT3 | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT1 | Total body irradiation | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | Total body irradiation | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT1 | Other | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT4 | CNS (cranial irradiation) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT2 | CNS (cranial irradiation) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | CNS (cranial irradiation) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT2 | Total body irradiation | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT4 | Total body irradiation | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT2 | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT5-LOT7 | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Location of Application of Radiotherapy | LOT3 | CNS (cranial irradiation) | 1 Participants |
Primary
Number of Participants According to Reason for Exposure to High Dose of Radiation
Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Reason for Exposure to High Dose of Radiation | Accidental exposures | 0 Participants |
| Newly AML | Number of Participants According to Reason for Exposure to High Dose of Radiation | Therapeutic radiation for other cancers | 2 Participants |
| Newly AML | Number of Participants According to Reason for Exposure to High Dose of Radiation | Other | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reason for Exposure to High Dose of Radiation | Therapeutic radiation for other cancers | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reason for Exposure to High Dose of Radiation | Accidental exposures | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reason for Exposure to High Dose of Radiation | Other | 1 Participants |
Primary
Number of Participants According to Reasons for Withdrawing Regimen
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT3) | 1 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT2) | 1 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT3) | 9 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT1) | 44 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT4) | 4 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT2) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT1) | 28 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT2) | 15 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT2) | 11 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT4) | 3 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT3) | 5 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT1) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT3) | 4 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT2) | 9 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT3) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT1) | 14 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT5-LOT7) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT1) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT1) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT1) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT1) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT1) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT2) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT2) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT2) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT2) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT2) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT3) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT3) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT3) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT4) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Other (LOT4) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Progression of the disease (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Adverse event-toxicity (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Participant's refusal to continue the treatment scheme (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Reasons for Withdrawing Regimen | Cost-related or access barriers (LOT5-LOT7) | 0 Participants |
Primary
Number of Participants According to Regimen Type in Newly AML
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.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Induction (LOT1) | 458 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Consolidation (LOT1) | 92 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Maintenance (LOT1) | 7 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Salvage (LOT1) | 2 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Other (LOT1) | 55 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Induction (LOT2) | 46 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Consolidation (LOT2) | 126 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Maintenance (LOT2) | 7 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Salvage (LOT2) | 93 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Other (LOT2) | 27 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Induction (LOT3) | 11 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Consolidation (LOT3) | 42 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Maintenance (LOT3) | 10 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Salvage (LOT3) | 73 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Other (LOT3) | 17 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Induction (LOT4) | 3 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Consolidation (LOT4) | 27 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Maintenance (LOT4) | 5 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Salvage (LOT4) | 22 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Other (LOT4) | 6 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Induction (LOT5-LOT7) | 1 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Consolidation (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Maintenance (LOT5-LOT7) | 4 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Salvage (LOT5-LOT7) | 16 Participants |
| Newly AML | Number of Participants According to Regimen Type in Newly AML | Other (LOT5-LOT7) | 5 Participants |
Primary
Number of Participants According to Year of Diagnosis
Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Year of Diagnosis | 2015 | 88 Participants |
| Newly AML | Number of Participants According to Year of Diagnosis | 2017 | 103 Participants |
| Newly AML | Number of Participants According to Year of Diagnosis | 2019 | 100 Participants |
| Newly AML | Number of Participants According to Year of Diagnosis | 2018 | 125 Participants |
| Newly AML | Number of Participants According to Year of Diagnosis | 2016 | 102 Participants |
| R/R B-cell ALL | Number of Participants According to Year of Diagnosis | 2019 | 18 Participants |
| R/R B-cell ALL | Number of Participants According to Year of Diagnosis | 2015 | 13 Participants |
| R/R B-cell ALL | Number of Participants According to Year of Diagnosis | 2016 | 15 Participants |
| R/R B-cell ALL | Number of Participants According to Year of Diagnosis | 2017 | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Year of Diagnosis | 2018 | 21 Participants |
Primary
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Gemtuzumab (LOT1) | 0 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Midostaurin (LOT1) | 10 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Venetoclax (LOT1) | 1 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Gemtuzumab (LOT2) | 1 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Midostaurin (LOT2) | 9 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Venetoclax (LOT2) | 3 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Gemtuzumab (LOT3) | 2 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Midostaurin (LOT3) | 3 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Venetoclax (LOT3) | 7 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Gemtuzumab (LOT4) | 0 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Midostaurin (LOT4) | 1 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Venetoclax (LOT4) | 2 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Gemtuzumab (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Midostaurin (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML | Venetoclax (LOT5-LOT7) | 3 Participants |
Primary
Number of Participants Who Withdrew Regimen
Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants Who Withdrew Regimen | LOT2 | 35 Participants |
| Newly AML | Number of Participants Who Withdrew Regimen | LOT4 | 8 Participants |
| Newly AML | Number of Participants Who Withdrew Regimen | LOT3 | 19 Participants |
| Newly AML | Number of Participants Who Withdrew Regimen | LOT5-LOT7 | 2 Participants |
| Newly AML | Number of Participants Who Withdrew Regimen | LOT1 | 86 Participants |
| R/R B-cell ALL | Number of Participants Who Withdrew Regimen | LOT5-LOT7 | 1 Participants |
| R/R B-cell ALL | Number of Participants Who Withdrew Regimen | LOT1 | 8 Participants |
| R/R B-cell ALL | Number of Participants Who Withdrew Regimen | LOT2 | 12 Participants |
| R/R B-cell ALL | Number of Participants Who Withdrew Regimen | LOT3 | 10 Participants |
| R/R B-cell ALL | Number of Participants Who Withdrew Regimen | LOT4 | 5 Participants |
Primary
Number of Participants With Bleeding History
Number of participants with bleeding history were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants With Bleeding History | 30 Participants |
| R/R B-cell ALL | Number of Participants With Bleeding History | 6 Participants |
Primary
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.
Time frame: At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT2 | 1 Participants |
| Newly AML | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT4 | 1 Participants |
| Newly AML | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT3 | 2 Participants |
| Newly AML | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT5-LOT7 | 0 Participants |
| Newly AML | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT1 | 1 Participants |
| R/R B-cell ALL | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT5-LOT7 | 0 Participants |
| R/R B-cell ALL | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT1 | 0 Participants |
| R/R B-cell ALL | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT2 | 1 Participants |
| R/R B-cell ALL | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT3 | 2 Participants |
| R/R B-cell ALL | Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression | LOT4 | 0 Participants |
Primary
Number of Participants With Comorbidities
Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants With Comorbidities | 273 Participants |
| R/R B-cell ALL | Number of Participants With Comorbidities | 23 Participants |
Primary
Number of Participants With Dose Reduction
Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants With Dose Reduction | LOT2 | 37 Participants |
| Newly AML | Number of Participants With Dose Reduction | LOT4 | 3 Participants |
| Newly AML | Number of Participants With Dose Reduction | LOT3 | 15 Participants |
| Newly AML | Number of Participants With Dose Reduction | LOT5-LOT7 | 1 Participants |
| Newly AML | Number of Participants With Dose Reduction | LOT1 | 84 Participants |
| R/R B-cell ALL | Number of Participants With Dose Reduction | LOT5-LOT7 | 1 Participants |
| R/R B-cell ALL | Number of Participants With Dose Reduction | LOT1 | 9 Participants |
| R/R B-cell ALL | Number of Participants With Dose Reduction | LOT2 | 7 Participants |
| R/R B-cell ALL | Number of Participants With Dose Reduction | LOT3 | 2 Participants |
| R/R B-cell ALL | Number of Participants With Dose Reduction | LOT4 | 1 Participants |
Primary
Number of Participants With Prior Exposure to a High Dose of Radiation
Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants With Prior Exposure to a High Dose of Radiation | 2 Participants |
| R/R B-cell ALL | Number of Participants With Prior Exposure to a High Dose of Radiation | 1 Participants |
Primary
Number of Participants With Prior Exposure to Toxic Agents
Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants With Prior Exposure to Toxic Agents | 11 Participants |
| R/R B-cell ALL | Number of Participants With Prior Exposure to Toxic Agents | 3 Participants |
Primary
Number of Participants With Stem Cell Transplant (SCT)
Number of participants with stem cell transplant were reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Newly AML | Number of Participants With Stem Cell Transplant (SCT) | 125 Participants |
| R/R B-cell ALL | Number of Participants With Stem Cell Transplant (SCT) | 26 Participants |
Primary
Number of Participants With Tobacco Consumption Habits
Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.
Time frame: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants With Tobacco Consumption Habits | Non-smoker | 343 Participants |
| Newly AML | Number of Participants With Tobacco Consumption Habits | Ex-smoker | 85 Participants |
| Newly AML | Number of Participants With Tobacco Consumption Habits | Other | 51 Participants |
| R/R B-cell ALL | Number of Participants With Tobacco Consumption Habits | Non-smoker | 55 Participants |
| R/R B-cell ALL | Number of Participants With Tobacco Consumption Habits | Ex-smoker | 10 Participants |
| R/R B-cell ALL | Number of Participants With Tobacco Consumption Habits | Other | 5 Participants |
Primary
Time to Next Treatment
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Newly AML | Time to Next Treatment | LOT2 to LOT3 | 2.9 Months |
| Newly AML | Time to Next Treatment | LOT4 to LOT5 | 4.2 Months |
| Newly AML | Time to Next Treatment | LOT1 to LOT2 | 1.6 Months |
| Newly AML | Time to Next Treatment | LOT5 to LOT6, LOT6 to LOT7 | 4.8 Months |
| Newly AML | Time to Next Treatment | LOT3 to LOT4 | 2.0 Months |
| R/R B-cell ALL | Time to Next Treatment | LOT5 to LOT6, LOT6 to LOT7 | 7.9 Months |
| R/R B-cell ALL | Time to Next Treatment | LOT2 to LOT3 | 2.6 Months |
| R/R B-cell ALL | Time to Next Treatment | LOT3 to LOT4 | 2.4 Months |
| R/R B-cell ALL | Time to Next Treatment | LOT4 to LOT5 | 2.7 Months |
| R/R B-cell ALL | Time to Next Treatment | LOT1 to LOT2 | 8.4 Months |
Primary
Total Number of Cycles
Total number of cycles according to each line of treatment is reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Total Number of Cycles | LOT1 | 2.2 Cycles | Standard Deviation 3.1 |
| Newly AML | Total Number of Cycles | LOT3 | 2.2 Cycles | Standard Deviation 3 |
| Newly AML | Total Number of Cycles | LOT5-LOT7 | 2.0 Cycles | Standard Deviation 1.9 |
| Newly AML | Total Number of Cycles | LOT4 | 2.0 Cycles | Standard Deviation 2.1 |
| Newly AML | Total Number of Cycles | LOT2 | 2.2 Cycles | Standard Deviation 2.6 |
| R/R B-cell ALL | Total Number of Cycles | LOT5-LOT7 | 1.4 Cycles | Standard Deviation 0.5 |
| R/R B-cell ALL | Total Number of Cycles | LOT1 | 3.1 Cycles | Standard Deviation 2.5 |
| R/R B-cell ALL | Total Number of Cycles | LOT2 | 2.7 Cycles | Standard Deviation 4 |
| R/R B-cell ALL | Total Number of Cycles | LOT3 | 2.6 Cycles | Standard Deviation 2 |
| R/R B-cell ALL | Total Number of Cycles | LOT4 | 6.5 Cycles | Standard Deviation 16.9 |
Primary
Treatment Duration
The duration of treatment according to different treatment lines were reported.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Newly AML | Treatment Duration | LOT2 | 2.2 Months | Standard Deviation 3.3 |
| Newly AML | Treatment Duration | LOT4 | 1.8 Months | Standard Deviation 2.5 |
| Newly AML | Treatment Duration | LOT3 | 2.3 Months | Standard Deviation 4.2 |
| Newly AML | Treatment Duration | LOT5-LOT7 | 2.2 Months | Standard Deviation 4.2 |
| Newly AML | Treatment Duration | LOT1 | 2.1 Months | Standard Deviation 4 |
| R/R B-cell ALL | Treatment Duration | LOT5-LOT7 | 2.6 Months | Standard Deviation 3.7 |
| R/R B-cell ALL | Treatment Duration | LOT1 | 6.4 Months | Standard Deviation 7.9 |
| R/R B-cell ALL | Treatment Duration | LOT2 | 3.9 Months | Standard Deviation 7.1 |
| R/R B-cell ALL | Treatment Duration | LOT3 | 1.7 Months | Standard Deviation 2 |
| R/R B-cell ALL | Treatment Duration | LOT4 | 6.0 Months | Standard Deviation 18.2 |
Secondary
Duration in Intensive Care Unit
Mean duration in intensive care unit were reported in this outcome measure.
Time frame: 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
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly AML | Duration in Intensive Care Unit | 9.1 Days | Standard Deviation 11.4 |
| R/R B-cell ALL | Duration in Intensive Care Unit | 11.4 Days | Standard Deviation 12.7 |
Secondary
Event Free Survival (EFS)
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Newly AML | Event Free Survival (EFS) | 1.5 Months |
| R/R B-cell ALL | Event Free Survival (EFS) | 1.8 Months |
Secondary
Number of Blood Transfusions
Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.
Time frame: 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
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Number of Blood Transfusions | Platelet | 1032 Blood transfusions |
| Newly AML | Number of Blood Transfusions | Whole blood | 63 Blood transfusions |
| Newly AML | Number of Blood Transfusions | Red blood cells | 1051 Blood transfusions |
| Newly AML | Number of Blood Transfusions | Other | 3 Blood transfusions |
| Newly AML | Number of Blood Transfusions | Plasma | 107 Blood transfusions |
| R/R B-cell ALL | Number of Blood Transfusions | Other | 1 Blood transfusions |
| R/R B-cell ALL | Number of Blood Transfusions | Platelet | 121 Blood transfusions |
| R/R B-cell ALL | Number of Blood Transfusions | Plasma | 16 Blood transfusions |
| R/R B-cell ALL | Number of Blood Transfusions | Red blood cells | 139 Blood transfusions |
| R/R B-cell ALL | Number of Blood Transfusions | Whole blood | 4 Blood transfusions |
Secondary
Number of Clinical Events
Number of clinical events were reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Number of Clinical Events | Hematological toxicities | 317 Events |
| Newly AML | Number of Clinical Events | Hepatotoxicity | 5 Events |
| Newly AML | Number of Clinical Events | Gastrointestinal toxicities | 86 Events |
| R/R B-cell ALL | Number of Clinical Events | Hematological toxicities | 86 Events |
| R/R B-cell ALL | Number of Clinical Events | Hepatotoxicity | 7 Events |
| R/R B-cell ALL | Number of Clinical Events | Gastrointestinal toxicities | 17 Events |
Secondary
Number of Concomitant Medications
Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.
Time frame: 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
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Number of Concomitant Medications | Vancomycin | 268 Medications |
| Newly AML | Number of Concomitant Medications | Meropenem | 252 Medications |
| Newly AML | Number of Concomitant Medications | Piperacillin; Tazobactam | 219 Medications |
| Newly AML | Number of Concomitant Medications | Other | 2604 Medications |
| R/R B-cell ALL | Number of Concomitant Medications | Other | 395 Medications |
| R/R B-cell ALL | Number of Concomitant Medications | Vancomycin | 36 Medications |
| R/R B-cell ALL | Number of Concomitant Medications | Piperacillin; Tazobactam | 36 Medications |
| R/R B-cell ALL | Number of Concomitant Medications | Meropenem | 34 Medications |
Secondary
Number of Hospitalizations
Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.
Time frame: 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
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Newly AML | Number of Hospitalizations | 880 Hospitalizations |
| R/R B-cell ALL | Number of Hospitalizations | 128 Hospitalizations |
Secondary
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
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.
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only | Good prognosis | 1 Participants |
| Newly AML | Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only | Intermediate prognosis | 16 Participants |
| Newly AML | Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only | Poor prognosis | 29 Participants |
| Newly AML | Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only | Undetermined prognosis | 6 Participants |
Secondary
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
Number of participants according to ALL WHO classification were reported in this outcome measure.
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma, NOS | 30 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with recurrent genetic abnormalities | 0 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2);BCR-ABL1 | 17 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with t(v;11q23.3);KMT2A rearranged | 3 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with t(12;21)(p13.2;q22.1); ETV6-RUNX1 | 0 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with hyperdiploidy | 1 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with hypodiploidy | 1 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with t(5;14)(q31.1;q32.3) IL3-IGH | 0 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | B-lymphoblastic leukemia/lymphoma with t(1;19)(q23;p13.3);TCF3-PBX1 | 0 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | Provisional entity: B-lymphoblastic leukemia/lymphoma, BCR-ABL1-like | 4 Participants |
| Newly AML | Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only | Provisional entity: B-lymphoblastic leukemia/lymphoma with iAMP21 | 0 Participants |
Secondary
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
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.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN) | Favorable | 85 Participants |
| Newly AML | Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN) | Intermediate | 179 Participants |
| Newly AML | Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN) | Poor/Adverse | 109 Participants |
Secondary
Number of Participants According to AML Translocation Results: AML Arm Only
Number of participants according to different AML translocation were reported in this outcome measure.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | t(8;21) | 22 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | inv(16) | 26 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | der(11q23) | 1 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | t(6;9) | 1 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | t(1;22) | 0 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | t(7;11) | 1 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | inv(3) | 4 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | t(16;21) | 0 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | del(7q) | 7 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | Monosomy 7(-7) | 9 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | Complex cytogenetics/Complex karyotypes | 40 Participants |
| Newly AML | Number of Participants According to AML Translocation Results: AML Arm Only | Other | 208 Participants |
Secondary
Number of Participants According to AML WHO Classification: AML Arm Only
Number of participants according to AML WHO classification were reported in this outcome measure.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with recurrent genetic abnormalities | 28 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with t(8;21)(q22;q22.1);RUNX1 | 19 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22);CBFB | 28 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | APL with PML | 0 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with t(9;11)(p21.3;q23.3);MLLT3 | 2 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with t(6;9)(p23;q34.1);DEK | 1 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM | 3 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML (megakaryoblastic) with t(1;22)(p13.3;q13.3);RBM15 | 0 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | Provisional entity: AML with BCR | 0 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with mutated NPM1 | 36 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with biallelic mutations of CEBPA | 3 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | Provisional entity: AML with mutated RUNX1 | 3 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML with myelodysplasia | 27 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | Therapy | 1 Participants |
| Newly AML | Number of Participants According to AML WHO Classification: AML Arm Only | AML, NOS | 240 Participants |
Secondary
Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | Hyper-CVAD (since de novo ALL diagnose date) | 13 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | GMALL (since de novo ALL diagnose date) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | GRAAL (since de novo ALL diagnose date) | 7 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | BFM (since de novo ALL diagnose date) | 16 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | Inotuzumab (since de novo ALL diagnose date) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | Blinatumomab (since de novo ALL diagnose date) | 1 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | Car T-cell (since de novo ALL diagnose date) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | TKI inhibitor (since de novo ALL diagnose date) | 5 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | FLAG (since de novo ALL diagnose date) | 0 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | FLAG-IDA (since de novo ALL diagnose date) | 2 Participants |
| Newly AML | Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL | Other (since de novo ALL diagnose date) | 28 Participants |
Secondary
Number of Participants According to Immunophenotyping Results for AML Arm Only
Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | AML_IP_RES | 7 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | cCD3 | 5 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | cCD79a | 9 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | MPO | 239 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD34 | 316 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD3 | 9 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD4 | 43 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD5 | 3 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD7 | 119 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD8 | 6 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | TdT | 2 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD10 | 14 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD19 | 30 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD20 | 6 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD13 | 364 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD33 | 354 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD14 | 49 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD36 | 87 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | HLADR | 376 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | glycophorin A | 1 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD41 | 1 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD61 | 4 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | CD117 | 400 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for AML Arm Only | Other | 327 Participants |
Secondary
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | TdT | 7 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD19 | 18 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD20 | 6 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD22 | 11 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD79a | 9 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | HLA Dr | 6 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD10 | 17 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD34 | 18 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | CD45 | 11 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | Cytoplasmic IgM | 1 Participants |
| Newly AML | Number of Participants According to Immunophenotyping Results for R/R B-cell ALL | Other | 9 Participants |
Secondary
Number of Participants According to Molecular Profile in Newly AML Arm
Number of participants according to molecular profile were reported in this outcome measure.
Time frame: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | ASXL1 | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | BCOR | 2 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | CEBPA | 13 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | CSF3R | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | DNMT3A | 9 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | EZH2 | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | IDH1 | 6 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | IDH2 | 3 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | KIT | 8 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | KRAS | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | NPM1 | 66 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | NRAS | 4 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | PTPN11 | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | RUNX1 | 16 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | SF3B1 | 0 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | SRSF2 | 2 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | STAG2 | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | TET2 | 4 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | TP53 | 5 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | U2AF1 | 0 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | ZRSR2 | 0 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | FLT3 | 94 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | MLL-PTD | 3 Participants |
| Newly AML | Number of Participants According to Molecular Profile in Newly AML Arm | Other | 125 Participants |
Secondary
Number of Participants According to Molecular Profile in R/R B-cell ALL
Number of participants according to molecular profile in R/R B-cell ALL were reported.
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | B-cell immunoglobulin gene rearrangement | 1 Participants |
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | inv(16) | 0 Participants |
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | der(11q23) | 21 Participants |
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | t(6;9) | 0 Participants |
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | t(4;11) | 3 Participants |
| Newly AML | Number of Participants According to Molecular Profile in R/R B-cell ALL | Other | 28 Participants |
Secondary
Number of Participants According to Surgery
Number of participants according to type of surgery were reported in this outcome measure.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Surgery | Abcess | 9 Participants |
| Newly AML | Number of Participants According to Surgery | Catheter | 2 Participants |
| Newly AML | Number of Participants According to Surgery | Tracheostomy | 4 Participants |
| Newly AML | Number of Participants According to Surgery | Other | 45 Participants |
| R/R B-cell ALL | Number of Participants According to Surgery | Other | 6 Participants |
| R/R B-cell ALL | Number of Participants According to Surgery | Abcess | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Surgery | Tracheostomy | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Surgery | Catheter | 2 Participants |
Secondary
Number of Participants According to Treatment Response
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants According to Treatment Response | Partial remission-response (LOT2) | 12 Participants |
| Newly AML | Number of Participants According to Treatment Response | Refractory disease (LOT3) | 47 Participants |
| Newly AML | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT1) | 12 Participants |
| Newly AML | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT3) | 8 Participants |
| Newly AML | Number of Participants According to Treatment Response | Progressive disease (LOT2) | 19 Participants |
| Newly AML | Number of Participants According to Treatment Response | Other (LOT3) | 11 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT1) | 16 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response (LOT4) | 27 Participants |
| Newly AML | Number of Participants According to Treatment Response | Refractory disease (LOT2) | 58 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT4) | 0 Participants |
| Newly AML | Number of Participants According to Treatment Response | Other (LOT1) | 36 Participants |
| Newly AML | Number of Participants According to Treatment Response | Partial remission-response (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT2) | 14 Participants |
| Newly AML | Number of Participants According to Treatment Response | Progressive disease (LOT4) | 6 Participants |
| Newly AML | Number of Participants According to Treatment Response | Progressive disease (LOT1) | 33 Participants |
| Newly AML | Number of Participants According to Treatment Response | Refractory disease (LOT4) | 18 Participants |
| Newly AML | Number of Participants According to Treatment Response | Other (LOT2) | 16 Participants |
| Newly AML | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT4) | 2 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response (LOT2) | 129 Participants |
| Newly AML | Number of Participants According to Treatment Response | Other (LOT4) | 1 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response (LOT3) | 54 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response (LOT5-LOT7) | 8 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response (LOT1) | 190 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT5-LOT7) | 2 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT3) | 2 Participants |
| Newly AML | Number of Participants According to Treatment Response | Partial remission-response (LOT5-LOT7) | 0 Participants |
| Newly AML | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT2) | 11 Participants |
| Newly AML | Number of Participants According to Treatment Response | Progressive disease (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Treatment Response | Partial remission-response (LOT3) | 2 Participants |
| Newly AML | Number of Participants According to Treatment Response | Refractory disease (LOT5-LOT7) | 8 Participants |
| Newly AML | Number of Participants According to Treatment Response | Partial remission-response (LOT1) | 27 Participants |
| Newly AML | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT5-LOT7) | 1 Participants |
| Newly AML | Number of Participants According to Treatment Response | Progressive disease (LOT3) | 9 Participants |
| Newly AML | Number of Participants According to Treatment Response | Other (LOT5-LOT7) | 3 Participants |
| Newly AML | Number of Participants According to Treatment Response | Refractory disease (LOT1) | 142 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Other (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response (LOT1) | 24 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT1) | 7 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Partial remission-response (LOT1) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Progressive disease (LOT1) | 9 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Refractory disease (LOT1) | 19 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT1) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Other (LOT1) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response (LOT2) | 12 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT2) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Partial remission-response (LOT2) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Progressive disease (LOT2) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Refractory disease (LOT2) | 18 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT2) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Other (LOT2) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response (LOT3) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT3) | 1 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Partial remission-response (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Progressive disease (LOT3) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Refractory disease (LOT3) | 12 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT3) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Other (LOT3) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response (LOT4) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Partial remission-response (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Progressive disease (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Refractory disease (LOT4) | 5 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT4) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Other (LOT4) | 3 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response (LOT5-LOT7) | 4 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Complete remission-response with incomplete hematological-count recovery (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Partial remission-response (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Progressive disease (LOT5-LOT7) | 0 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Refractory disease (LOT5-LOT7) | 2 Participants |
| R/R B-cell ALL | Number of Participants According to Treatment Response | Relapsed from CR or CRi or recurrent disease (LOT5-LOT7) | 0 Participants |
Secondary
Number of Participants With Molecular Test Performed
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.
Time frame: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Newly AML | Number of Participants With Molecular Test Performed | KGB | 381 Participants |
| Newly AML | Number of Participants With Molecular Test Performed | FISH | 112 Participants |
| Newly AML | Number of Participants With Molecular Test Performed | RT-PCR | 247 Participants |
| Newly AML | Number of Participants With Molecular Test Performed | NGS | 33 Participants |
| Newly AML | Number of Participants With Molecular Test Performed | ACGH | 0 Participants |
| Newly AML | Number of Participants With Molecular Test Performed | Other | 23 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | ACGH | 0 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | KGB | 52 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | NGS | 1 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | FISH | 31 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | Other | 3 Participants |
| R/R B-cell ALL | Number of Participants With Molecular Test Performed | RT-PCR | 40 Participants |
Secondary
Number of Procedures
Different clinical procedures were reported. One participant could have more than one procedure.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Number of Procedures | Surgery | 60 Procedures |
| Newly AML | Number of Procedures | Image exams | 1187 Procedures |
| Newly AML | Number of Procedures | Laboratory exams | 1494 Procedures |
| Newly AML | Number of Procedures | Blood transfusions | 1128 Procedures |
| Newly AML | Number of Procedures | Associated treatments for infections | 1062 Procedures |
| Newly AML | Number of Procedures | Use of mechanical ventilation | 141 Procedures |
| Newly AML | Number of Procedures | Use of parenteral feeding | 231 Procedures |
| Newly AML | Number of Procedures | Other | 70 Procedures |
| R/R B-cell ALL | Number of Procedures | Other | 19 Procedures |
| R/R B-cell ALL | Number of Procedures | Surgery | 8 Procedures |
| R/R B-cell ALL | Number of Procedures | Associated treatments for infections | 153 Procedures |
| R/R B-cell ALL | Number of Procedures | Image exams | 172 Procedures |
| R/R B-cell ALL | Number of Procedures | Use of parenteral feeding | 11 Procedures |
| R/R B-cell ALL | Number of Procedures | Laboratory exams | 311 Procedures |
| R/R B-cell ALL | Number of Procedures | Use of mechanical ventilation | 18 Procedures |
| R/R B-cell ALL | Number of Procedures | Blood transfusions | 162 Procedures |
Secondary
Overall Survival (OS)
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Newly AML | Overall Survival (OS) | 10.6 Months |
| R/R B-cell ALL | Overall Survival (OS) | 19.2 Months |
Secondary
Reason for Hospitalization
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.
Time frame: 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
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Reason for Hospitalization | ALL-AML Treatment | 1064 Hospitalization |
| Newly AML | Reason for Hospitalization | Adverse events | 20 Hospitalization |
| Newly AML | Reason for Hospitalization | Other | 559 Hospitalization |
| R/R B-cell ALL | Reason for Hospitalization | ALL-AML Treatment | 236 Hospitalization |
| R/R B-cell ALL | Reason for Hospitalization | Adverse events | 4 Hospitalization |
| R/R B-cell ALL | Reason for Hospitalization | Other | 134 Hospitalization |
Secondary
Relapse Free Survival-Newly Diagnosed AML Participants Only
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Newly AML | Relapse Free Survival-Newly Diagnosed AML Participants Only | 3.9 Months |
Secondary
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.
Time frame: 1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Newly AML | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 3 years | 28.0 Percentage of participants |
| Newly AML | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 1 year | 47.7 Percentage of participants |
| Newly AML | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 5 years | 24.5 Percentage of participants |
| R/R B-cell ALL | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 1 year | 67.6 Percentage of participants |
| R/R B-cell ALL | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 3 years | 35.2 Percentage of participants |
| R/R B-cell ALL | Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation | 5 years | 19.7 Percentage of participants |
Secondary
Time From Start of First-Line Treatment to Start of the Adverse Event
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.
Time frame: From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly AML | Time From Start of First-Line Treatment to Start of the Adverse Event | 56.0 Months | Standard Deviation 15.8 |
| R/R B-cell ALL | Time From Start of First-Line Treatment to Start of the Adverse Event | 39.5 Months | Standard Deviation 28 |