Latin American Real-world Study in Acute Leukemia

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 such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.

Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.

Number of participants who had a family history of hematological malignancies were reported in this outcome measure.

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 were reported in this outcome measure.

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 were reported in this outcome measure.

Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.

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.

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 the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.

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.

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.

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 according to different LOT were reported in this outcome measure.

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.

The duration of treatment according to different treatment lines were reported.

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 according to each line of treatment is reported in this outcome measure.

Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.

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 according to each line of treatment were reported in this outcome measure.

Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.

Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.

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 according to each line of treatment is reported in this outcome measure.

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 were reported in this outcome measure.

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 according to each line of treatment was reported in this outcome measure.

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 according to each line of treatment was reported in this outcome measure.

Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.

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 start of treatment according to each line of treatment was reported in this outcome measure.

Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.

Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.

Absolute value of platelet count after start of treatment according to different treatment lines were reported.

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.

Number of participants according to different AML translocation were reported in this outcome measure.

Number of participants according to molecular profile were reported in this outcome measure.

Number of participants according to AML WHO classification were reported in this outcome measure.

Number of participants according to ALL WHO classification were reported in this outcome measure.

Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.

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 were reported.

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)" 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.

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 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 were reported in this outcome measure.

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.

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.

Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.

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.

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 were reported in this outcome measure. One participant could have more than one 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.

Mean duration in intensive care unit were reported in this outcome measure.

Different clinical procedures were reported. One participant could have more than one procedure.

Number of participants according to type of surgery were reported in this outcome measure.

Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.

Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.