Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study

Number of Participants According to Karnofsky Performance Scores

时间窗: 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

时间窗: 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

时间窗: 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.

Number of Participants According to Drug Regimen Prescribed for Newly AML

时间窗: 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 Health Insurance Type

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 Drug Regimen Prescribed for R/R B-cell ALL

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Absolute Value of Hemoglobin After Start of Treatment Line

时间窗: 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

时间窗: 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.

Dose of Radiotherapy

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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 White Blood Cell Count After Start of Treatment Line

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Absolute Value of Platelets Count After Start of Treatment Line

时间窗: 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.