Trial Outcomes & Findings for Latin American Real-world Study in Acute Leukemia (NCT NCT05166135)
NCT ID: NCT05166135
Last Updated: 2025-03-25
Results Overview
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.
COMPLETED
589 participants
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
2025-03-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
518
|
71
|
|
Overall Study
COMPLETED
|
518
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
Baseline characteristics by cohort
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
Total
n=589 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 16.7 • n=518 Participants
|
36.6 Years
STANDARD_DEVIATION 15.5 • n=71 Participants
|
52.5 Years
STANDARD_DEVIATION 17.6 • n=589 Participants
|
|
Sex: Female, Male
Female
|
264 Participants
n=518 Participants
|
31 Participants
n=71 Participants
|
295 Participants
n=589 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=518 Participants
|
40 Participants
n=71 Participants
|
294 Participants
n=589 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
38 Participants
n=493 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
9 Participants
n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
47 Participants
n=559 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=493 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
0 Participants
n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
2 Participants
n=559 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=493 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
4 Participants
n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
25 Participants
n=559 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
|
Race/Ethnicity, Customized
White or Caucasian
|
363 Participants
n=493 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
33 Participants
n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
396 Participants
n=559 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
|
Race/Ethnicity, Customized
Other
|
69 Participants
n=493 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
20 Participants
n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
89 Participants
n=559 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the baseline measure.
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants according to type of health insurance (public or private) were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants According to Health Insurance Type
Private
|
265 Participants
|
44 Participants
|
|
Number of Participants According to Health Insurance Type
Public
|
253 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants According to Country of Residence
Argentina
|
166 Participants
|
23 Participants
|
|
Number of Participants According to Country of Residence
Brazil
|
205 Participants
|
27 Participants
|
|
Number of Participants According to Country of Residence
Chile
|
63 Participants
|
0 Participants
|
|
Number of Participants According to Country of Residence
Colombia
|
84 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Comorbidities
|
273 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants who had a family history of hematological malignancies were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants According to Family History of Hematological Malignancies
|
21 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Prior Exposure to Toxic Agents
|
11 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Prior Exposure to a High Dose of Radiation
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: 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 of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=2 Participants
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.
|
R/R B-cell ALL
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants According to Reason for Exposure to High Dose of Radiation
Accidental exposures
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reason for Exposure to High Dose of Radiation
Other
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Reason for Exposure to High Dose of Radiation
Therapeutic radiation for other cancers
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants with bleeding history were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Bleeding History
|
30 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: 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.
Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=479 Participants
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.
|
R/R B-cell ALL
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants With Tobacco Consumption Habits
Non-smoker
|
343 Participants
|
55 Participants
|
|
Number of Participants With Tobacco Consumption Habits
Ex-smoker
|
85 Participants
|
10 Participants
|
|
Number of Participants With Tobacco Consumption Habits
Other
|
51 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=387 Participants
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.
|
R/R B-cell ALL
n=57 Participants
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.
|
|---|---|---|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
0
|
136 Participants
|
29 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
1
|
185 Participants
|
21 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
2
|
45 Participants
|
7 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
3
|
16 Participants
|
0 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
4
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=337 Participants
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.
|
R/R B-cell ALL
n=50 Participants
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.
|
|---|---|---|
|
Number of Participants According to Karnofsky Performance Scores
100
|
110 Participants
|
27 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
90
|
107 Participants
|
12 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
80
|
69 Participants
|
7 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
70
|
29 Participants
|
2 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
60
|
4 Participants
|
2 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
50
|
14 Participants
|
0 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
40
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
30
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
20
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Karnofsky Performance Scores
10
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants According to Year of Diagnosis
2016
|
102 Participants
|
15 Participants
|
|
Number of Participants According to Year of Diagnosis
2015
|
88 Participants
|
13 Participants
|
|
Number of Participants According to Year of Diagnosis
2017
|
103 Participants
|
4 Participants
|
|
Number of Participants According to Year of Diagnosis
2018
|
125 Participants
|
21 Participants
|
|
Number of Participants According to Year of Diagnosis
2019
|
100 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=489 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT1 · Fit
|
390 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT1 · Unfit
|
99 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT2 · Fit
|
217 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT2 · Unfit
|
43 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT3 · Fit
|
102 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT3 · Unfit
|
32 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT4 · Fit
|
40 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT4 · Unfit
|
13 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT5-LOT7 · Fit
|
15 Participants
|
—
|
|
Number of Participants According to Classification for Standard Newly AML Therapy
LOT5-LOT7 · Unfit
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Standard 7+3 (LOT1)
|
390 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HDAC (LOT1)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
LDAC (LOT1)
|
25 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG (LOT1)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG-IDA (LOT1)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HMA (LOT1)
|
47 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
CLAG (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MEC (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MICE (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Other (LOT1)
|
47 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Standard 7+3 (LOT2)
|
9 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HDAC (LOT2)
|
85 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
LDAC (LOT2)
|
7 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG (LOT2)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG-IDA (LOT2)
|
66 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HMA (LOT2)
|
26 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
CLAG (LOT2)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MEC (LOT2)
|
24 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MICE (LOT2)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Other (LOT2)
|
56 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Standard 7+3 (LOT3)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HDAC (LOT3)
|
24 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
LDAC (LOT3)
|
5 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG (LOT3)
|
5 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG-IDA (LOT3)
|
36 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HMA (LOT3)
|
30 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
CLAG (LOT3)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MEC (LOT3)
|
9 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MICE (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Other (LOT3)
|
31 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Standard 7+3 (LOT4)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HDAC (LOT4)
|
20 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
LDAC (LOT4)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG-IDA (LOT4)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HMA (LOT4)
|
13 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
CLAG (LOT4)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MEC (LOT4)
|
5 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MICE (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Other (LOT4)
|
14 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Standard 7+3 (LOT5-LOT7)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HDAC (LOT5-LOT7)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
LDAC (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
FLAG-IDA (LOT5-LOT7)
|
7 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
HMA (LOT5-LOT7)
|
4 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
CLAG (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MEC (LOT5-LOT7)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
MICE (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for Newly AML
Other (LOT5-LOT7)
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=71 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Hyper-CVAD (LOT1)
|
16 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GMALL (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GRAAL (LOT1)
|
11 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
BFM (LOT1)
|
15 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Inotuzumab (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Blinatumomab (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Car T-cell (LOT1)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
TKI inhibitor (LOT1)
|
4 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG (LOT1)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG-IDA (LOT1)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Other (LOT1)
|
29 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Hyper-CVAD (LOT2)
|
14 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GMALL (LOT2)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GRAAL (LOT2)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
BFM (LOT2)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Inotuzumab (LOT2)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Blinatumomab (LOT2)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Car T-cell (LOT2)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
TKI inhibitor (LOT2)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG (LOT2)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG-IDA (LOT2)
|
15 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Other (LOT2)
|
22 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Hyper-CVAD (LOT3)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GMALL (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GRAAL (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
BFM (LOT3)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Inotuzumab (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Blinatumomab (LOT3)
|
5 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Car T-cell (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
TKI inhibitor (LOT3)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG (LOT3)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG-IDA (LOT3)
|
5 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Other (LOT3)
|
12 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Hyper-CVAD (LOT4)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GMALL (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GRAAL (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
BFM (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Inotuzumab (LOT4)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Blinatumomab (LOT4)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Car T-cell (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
TKI inhibitor (LOT4)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG (LOT4)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG-IDA (LOT4)
|
3 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Other (LOT4)
|
7 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Hyper-CVAD (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GMALL (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
GRAAL (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
BFM (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Inotuzumab (LOT5-LOT7)
|
2 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Blinatumomab (LOT5-LOT7)
|
1 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Car T-cell (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
TKI inhibitor (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
FLAG-IDA (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL
Other (LOT5-LOT7)
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=41 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Gemtuzumab (LOT1)
|
0 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Midostaurin (LOT1)
|
10 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Venetoclax (LOT1)
|
1 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Gemtuzumab (LOT2)
|
1 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Midostaurin (LOT2)
|
9 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Venetoclax (LOT2)
|
3 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Gemtuzumab (LOT3)
|
2 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Midostaurin (LOT3)
|
3 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Venetoclax (LOT3)
|
7 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Gemtuzumab (LOT4)
|
0 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Midostaurin (LOT4)
|
1 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Venetoclax (LOT4)
|
2 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Gemtuzumab (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Midostaurin (LOT5-LOT7)
|
0 Participants
|
—
|
|
Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML
Venetoclax (LOT5-LOT7)
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=515 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Regimen Type in Newly AML
Induction (LOT1)
|
458 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Consolidation (LOT1)
|
92 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Maintenance (LOT1)
|
7 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Salvage (LOT1)
|
2 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Other (LOT1)
|
55 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Induction (LOT2)
|
46 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Consolidation (LOT2)
|
126 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Maintenance (LOT2)
|
7 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Salvage (LOT2)
|
93 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Other (LOT2)
|
27 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Induction (LOT3)
|
11 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Consolidation (LOT3)
|
42 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Maintenance (LOT3)
|
10 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Salvage (LOT3)
|
73 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Other (LOT3)
|
17 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Induction (LOT4)
|
3 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Consolidation (LOT4)
|
27 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Maintenance (LOT4)
|
5 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Salvage (LOT4)
|
22 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Other (LOT4)
|
6 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Induction (LOT5-LOT7)
|
1 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Consolidation (LOT5-LOT7)
|
3 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Maintenance (LOT5-LOT7)
|
4 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Salvage (LOT5-LOT7)
|
16 Participants
|
—
|
|
Number of Participants According to Regimen Type in Newly AML
Other (LOT5-LOT7)
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
The duration of treatment according to different treatment lines were reported.
Outcome measures
| Measure |
Newly AML
n=503 Participants
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.
|
R/R B-cell ALL
n=67 Participants
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.
|
|---|---|---|
|
Treatment Duration
LOT1
|
2.1 Months
Standard Deviation 4.0
|
6.4 Months
Standard Deviation 7.9
|
|
Treatment Duration
LOT2
|
2.2 Months
Standard Deviation 3.3
|
3.9 Months
Standard Deviation 7.1
|
|
Treatment Duration
LOT3
|
2.3 Months
Standard Deviation 4.2
|
1.7 Months
Standard Deviation 2.0
|
|
Treatment Duration
LOT4
|
1.8 Months
Standard Deviation 2.5
|
6.0 Months
Standard Deviation 18.2
|
|
Treatment Duration
LOT5-LOT7
|
2.2 Months
Standard Deviation 4.2
|
2.6 Months
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: From start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 monthPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=275 Participants
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.
|
R/R B-cell ALL
n=53 Participants
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.
|
|---|---|---|
|
Time to Next Treatment
LOT1 to LOT2
|
1.6 Months
Interval 1.5 to 1.7
|
8.4 Months
Interval 6.1 to 14.5
|
|
Time to Next Treatment
LOT2 to LOT3
|
2.9 Months
Interval 2.2 to 4.8
|
2.6 Months
Interval 1.8 to 13.5
|
|
Time to Next Treatment
LOT3 to LOT4
|
2.0 Months
Interval 1.5 to 2.6
|
2.4 Months
Interval 1.8 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
|
Time to Next Treatment
LOT4 to LOT5
|
4.2 Months
Interval 3.0 to 8.2
|
2.7 Months
Interval 2.1 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
|
Time to Next Treatment
LOT5 to LOT6, LOT6 to LOT7
|
4.8 Months
Interval 4.2 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
7.9 Months
Interval 2.5 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Total number of cycles according to each line of treatment is reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=486 Participants
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.
|
R/R B-cell ALL
n=64 Participants
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.
|
|---|---|---|
|
Total Number of Cycles
LOT1
|
2.2 Cycles
Standard Deviation 3.1
|
3.1 Cycles
Standard Deviation 2.5
|
|
Total Number of Cycles
LOT2
|
2.2 Cycles
Standard Deviation 2.6
|
2.7 Cycles
Standard Deviation 4.0
|
|
Total Number of Cycles
LOT3
|
2.2 Cycles
Standard Deviation 3.0
|
2.6 Cycles
Standard Deviation 2.0
|
|
Total Number of Cycles
LOT4
|
2.0 Cycles
Standard Deviation 2.1
|
6.5 Cycles
Standard Deviation 16.9
|
|
Total Number of Cycles
LOT5-LOT7
|
2.0 Cycles
Standard Deviation 1.9
|
1.4 Cycles
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=502 Participants
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.
|
R/R B-cell ALL
n=70 Participants
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.
|
|---|---|---|
|
Number of Participants Who Withdrew Regimen
LOT1
|
86 Participants
|
8 Participants
|
|
Number of Participants Who Withdrew Regimen
LOT2
|
35 Participants
|
12 Participants
|
|
Number of Participants Who Withdrew Regimen
LOT3
|
19 Participants
|
10 Participants
|
|
Number of Participants Who Withdrew Regimen
LOT4
|
8 Participants
|
5 Participants
|
|
Number of Participants Who Withdrew Regimen
LOT5-LOT7
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=86 Participants
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.
|
R/R B-cell ALL
n=12 Participants
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.
|
|---|---|---|
|
Number of Participants According to Reasons for Withdrawing Regimen
Other (LOT2)
|
15 Participants
|
5 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Progression of the disease (LOT1)
|
14 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Adverse event-toxicity (LOT1)
|
28 Participants
|
2 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Participant's refusal to continue the treatment scheme (LOT1)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Cost-related or access barriers (LOT1)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Other (LOT1)
|
44 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Progression of the disease (LOT2)
|
11 Participants
|
3 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Adverse event-toxicity (LOT2)
|
9 Participants
|
4 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Participant's refusal to continue the treatment scheme (LOT2)
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Cost-related or access barriers (LOT2)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Progression of the disease (LOT3)
|
5 Participants
|
4 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Adverse event-toxicity (LOT3)
|
4 Participants
|
1 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Participant's refusal to continue the treatment scheme (LOT3)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Cost-related or access barriers (LOT3)
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Other (LOT3)
|
9 Participants
|
5 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Progression of the disease (LOT4)
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Adverse event-toxicity (LOT4)
|
1 Participants
|
2 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Participant's refusal to continue the treatment scheme (LOT4)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Cost-related or access barriers (LOT4)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Other (LOT4)
|
3 Participants
|
2 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Progression of the disease (LOT5-LOT7)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Adverse event-toxicity (LOT5-LOT7)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Participant's refusal to continue the treatment scheme (LOT5-LOT7)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Cost-related or access barriers (LOT5-LOT7)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Reasons for Withdrawing Regimen
Other (LOT5-LOT7)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=487 Participants
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.
|
R/R B-cell ALL
n=67 Participants
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.
|
|---|---|---|
|
Number of Participants With Dose Reduction
LOT1
|
84 Participants
|
9 Participants
|
|
Number of Participants With Dose Reduction
LOT2
|
37 Participants
|
7 Participants
|
|
Number of Participants With Dose Reduction
LOT3
|
15 Participants
|
2 Participants
|
|
Number of Participants With Dose Reduction
LOT4
|
3 Participants
|
1 Participants
|
|
Number of Participants With Dose Reduction
LOT5-LOT7
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=33 Participants
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.
|
R/R B-cell ALL
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
LOT1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
LOT2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
LOT3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
LOT4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression
LOT5-LOT7
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=2 Participants
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.
|
R/R B-cell ALL
n=3 Participants
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.
|
|---|---|---|
|
Duration of Radiotherapy
LOT1
|
0.3 Months
Standard Deviation 0
|
0.7 Months
Standard Deviation 0.6
|
|
Duration of Radiotherapy
LOT3
|
0.5 Months
|
—
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=3 Participants
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.
|
R/R B-cell ALL
n=3 Participants
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.
|
|---|---|---|
|
Dose of Radiotherapy
LOT1
|
300 Rad
Standard Deviation NA
Standard deviation could not be calculated as only one participants was analyzed.
|
2267 Rad
Standard Deviation 1553
|
|
Dose of Radiotherapy
LOT2
|
25 Rad
Standard Deviation NA
Standard deviation could not be calculated as only one participants was analyzed.
|
—
|
|
Dose of Radiotherapy
LOT3
|
2400 Rad
Standard Deviation NA
Standard deviation could not be calculated as only one participants was analyzed.
|
24 Rad
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=2 Participants
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.
|
R/R B-cell ALL
n=3 Participants
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.
|
|---|---|---|
|
Number of Participants According to Location of Application of Radiotherapy
LOT4 · Other
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT1 · CNS (cranial irradiation)
|
0 Participants
|
2 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT1 · Total body irradiation
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT1 · Other
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT2 · CNS (cranial irradiation)
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT2 · Total body irradiation
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT2 · Other
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT3 · CNS (cranial irradiation)
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT3 · Total body irradiation
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT3 · Other
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT4 · CNS (cranial irradiation)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT4 · Total body irradiation
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT5-LOT7 · CNS (cranial irradiation)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT5-LOT7 · Total body irradiation
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Location of Application of Radiotherapy
LOT5-LOT7 · Other
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=509 Participants
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.
|
R/R B-cell ALL
n=69 Participants
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.
|
|---|---|---|
|
Number of Participants According to Intrathecal Chemotherapy
Intrathecal chemotherapy (LOT1)
|
75 Participants
|
49 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Methotrexate (LOT1)
|
42 Participants
|
46 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Cytarabine (LOT1)
|
74 Participants
|
44 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Prednisone (LOT1)
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Dexamethasone (LOT1)
|
70 Participants
|
41 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Other (LOT1)
|
5 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Intrathecal chemotherapy (LOT2)
|
35 Participants
|
29 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Methotrexate (LOT2)
|
18 Participants
|
28 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Cytarabine (LOT2)
|
33 Participants
|
24 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Prednisone (LOT2)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Dexamethasone (LOT2)
|
32 Participants
|
25 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Other (LOT2)
|
4 Participants
|
1 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Intrathecal chemotherapy (LOT3)
|
10 Participants
|
10 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Methotrexate (LOT3)
|
6 Participants
|
10 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Cytarabine (LOT3)
|
9 Participants
|
8 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Prednisone (LOT3)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Dexamethasone (LOT3)
|
8 Participants
|
9 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Other (LOT3)
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Intrathecal chemotherapy (LOT4)
|
6 Participants
|
5 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Methotrexate (LOT4)
|
5 Participants
|
4 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Cytarabine (LOT4)
|
6 Participants
|
5 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Prednisone (LOT4)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Dexamethasone (LOT4)
|
2 Participants
|
5 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Other (LOT4)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Intrathecal chemotherapy (LOT5-LOT7)
|
3 Participants
|
2 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Methotrexate (LOT5-LOT7)
|
2 Participants
|
2 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Cytarabine (LOT5-LOT7)
|
3 Participants
|
2 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Prednisone (LOT5-LOT7)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Dexamethasone (LOT5-LOT7)
|
2 Participants
|
2 Participants
|
|
Number of Participants According to Intrathecal Chemotherapy
Other (LOT5-LOT7)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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 of participants with stem cell transplant were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=516 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Participants With Stem Cell Transplant (SCT)
|
125 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=470 Participants
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.
|
R/R B-cell ALL
n=59 Participants
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.
|
|---|---|---|
|
Absolute Value of Hemoglobin Before Treatment Line
LOT1
|
8.3 Grams per deciliter
Standard Deviation 1.7
|
9.2 Grams per deciliter
Standard Deviation 2.2
|
|
Absolute Value of Hemoglobin Before Treatment Line
LOT2
|
9.2 Grams per deciliter
Standard Deviation 1.8
|
10.4 Grams per deciliter
Standard Deviation 2.2
|
|
Absolute Value of Hemoglobin Before Treatment Line
LOT3
|
9.3 Grams per deciliter
Standard Deviation 2.1
|
9.9 Grams per deciliter
Standard Deviation 2.3
|
|
Absolute Value of Hemoglobin Before Treatment Line
LOT4
|
9.2 Grams per deciliter
Standard Deviation 1.5
|
9.4 Grams per deciliter
Standard Deviation 2.2
|
|
Absolute Value of Hemoglobin Before Treatment Line
LOT5-LOT7
|
9.5 Grams per deciliter
Standard Deviation 2.2
|
9.9 Grams per deciliter
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=416 Participants
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.
|
R/R B-cell ALL
n=55 Participants
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.
|
|---|---|---|
|
Absolute Value of Hemoglobin After Start of Treatment Line
LOT1
|
8.3 Grams per deciliter
Standard Deviation 1.6
|
10.0 Grams per deciliter
Standard Deviation 2.2
|
|
Absolute Value of Hemoglobin After Start of Treatment Line
LOT2
|
8.7 Grams per deciliter
Standard Deviation 1.6
|
9.3 Grams per deciliter
Standard Deviation 2.3
|
|
Absolute Value of Hemoglobin After Start of Treatment Line
LOT3
|
8.9 Grams per deciliter
Standard Deviation 2.1
|
9.5 Grams per deciliter
Standard Deviation 2.3
|
|
Absolute Value of Hemoglobin After Start of Treatment Line
LOT4
|
8.6 Grams per deciliter
Standard Deviation 1.4
|
8.5 Grams per deciliter
Standard Deviation 1.7
|
|
Absolute Value of Hemoglobin After Start of Treatment Line
LOT5-LOT7
|
8.7 Grams per deciliter
Standard Deviation 1.6
|
9.2 Grams per deciliter
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Up to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=471 Participants
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.
|
R/R B-cell ALL
n=59 Participants
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.
|
|---|---|---|
|
Absolute Value of White Blood Cell Count Before Treatment Line
LOT1
|
41.7 10^9cells per Liter
Standard Deviation 168.6
|
35.7 10^9cells per Liter
Standard Deviation 58.1
|
|
Absolute Value of White Blood Cell Count Before Treatment Line
LOT2
|
12.6 10^9cells per Liter
Standard Deviation 33.6
|
26.8 10^9cells per Liter
Standard Deviation 48.4
|
|
Absolute Value of White Blood Cell Count Before Treatment Line
LOT3
|
17.4 10^9cells per Liter
Standard Deviation 34.0
|
26.4 10^9cells per Liter
Standard Deviation 58.6
|
|
Absolute Value of White Blood Cell Count Before Treatment Line
LOT4
|
7.9 10^9cells per Liter
Standard Deviation 13.7
|
32.4 10^9cells per Liter
Standard Deviation 69.3
|
|
Absolute Value of White Blood Cell Count Before Treatment Line
LOT5-LOT7
|
15.7 10^9cells per Liter
Standard Deviation 39.3
|
17.0 10^9cells per Liter
Standard Deviation 29.8
|
PRIMARY outcome
Timeframe: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=416 Participants
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.
|
R/R B-cell ALL
n=55 Participants
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.
|
|---|---|---|
|
Absolute Value of White Blood Cell Count After Start of Treatment Line
LOT1
|
7.8 10^9cells per Liter
Standard Deviation 20.4
|
6.4 10^9cells per Liter
Standard Deviation 6.7
|
|
Absolute Value of White Blood Cell Count After Start of Treatment Line
LOT2
|
6.7 10^9cells per Liter
Standard Deviation 18.3
|
10.7 10^9cells per Liter
Standard Deviation 32.4
|
|
Absolute Value of White Blood Cell Count After Start of Treatment Line
LOT3
|
16.3 10^9cells per Liter
Standard Deviation 70.2
|
7.9 10^9cells per Liter
Standard Deviation 18.2
|
|
Absolute Value of White Blood Cell Count After Start of Treatment Line
LOT4
|
12.0 10^9cells per Liter
Standard Deviation 40.7
|
4.9 10^9cells per Liter
Standard Deviation 9.3
|
|
Absolute Value of White Blood Cell Count After Start of Treatment Line
LOT5-LOT7
|
6.8 10^9cells per Liter
Standard Deviation 13.0
|
3.1 10^9cells per Liter
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=432 Participants
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.
|
R/R B-cell ALL
n=57 Participants
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.
|
|---|---|---|
|
Absolute Neutrophil Count (ANC) Before Treatment Line
LOT1
|
5.0 10^9cells per Liter
Standard Deviation 21.0
|
4.5 10^9cells per Liter
Standard Deviation 6.5
|
|
Absolute Neutrophil Count (ANC) Before Treatment Line
LOT2
|
6.3 10^9cells per Liter
Standard Deviation 13.7
|
5.7 10^9cells per Liter
Standard Deviation 9.3
|
|
Absolute Neutrophil Count (ANC) Before Treatment Line
LOT3
|
8.8 10^9cells per Liter
Standard Deviation 20.1
|
2.1 10^9cells per Liter
Standard Deviation 2.0
|
|
Absolute Neutrophil Count (ANC) Before Treatment Line
LOT4
|
11.0 10^9cells per Liter
Standard Deviation 23.8
|
1.9 10^9cells per Liter
Standard Deviation 2.1
|
|
Absolute Neutrophil Count (ANC) Before Treatment Line
LOT5-LOT7
|
15.1 10^9cells per Liter
Standard Deviation 31.4
|
3.7 10^9cells per Liter
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=376 Participants
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.
|
R/R B-cell ALL
n=52 Participants
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.
|
|---|---|---|
|
Absolute Neutrophil Count (ANC) After Start of Treatment Line
LOT3
|
7.4 10^9cells per Liter
Standard Deviation 19.4
|
1.9 10^9cells per Liter
Standard Deviation 2.8
|
|
Absolute Neutrophil Count (ANC) After Start of Treatment Line
LOT4
|
12.4 10^9cells per Liter
Standard Deviation 28.2
|
13.9 10^9cells per Liter
Standard Deviation 27.5
|
|
Absolute Neutrophil Count (ANC) After Start of Treatment Line
LOT5-LOT7
|
18.5 10^9cells per Liter
Standard Deviation 32.4
|
2.1 10^9cells per Liter
Standard Deviation 2.2
|
|
Absolute Neutrophil Count (ANC) After Start of Treatment Line
LOT1
|
4.1 10^9cells per Liter
Standard Deviation 10.5
|
6.8 10^9cells per Liter
Standard Deviation 18.7
|
|
Absolute Neutrophil Count (ANC) After Start of Treatment Line
LOT2
|
4.9 10^9cells per Liter
Standard Deviation 13.9
|
4.4 10^9cells per Liter
Standard Deviation 9.7
|
PRIMARY outcome
Timeframe: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=416 Participants
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.
|
R/R B-cell ALL
n=52 Participants
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.
|
|---|---|---|
|
Absolute Value of Blast Count Before Treatment Line
LOT1
|
37.5 Percentage of blast cells
Standard Deviation 33.4
|
36.4 Percentage of blast cells
Standard Deviation 35.0
|
|
Absolute Value of Blast Count Before Treatment Line
LOT2
|
12.0 Percentage of blast cells
Standard Deviation 26.1
|
16.9 Percentage of blast cells
Standard Deviation 30.0
|
|
Absolute Value of Blast Count Before Treatment Line
LOT3
|
22.4 Percentage of blast cells
Standard Deviation 35.8
|
20.4 Percentage of blast cells
Standard Deviation 30.5
|
|
Absolute Value of Blast Count Before Treatment Line
LOT4
|
11.2 Percentage of blast cells
Standard Deviation 25.8
|
12.7 Percentage of blast cells
Standard Deviation 27.7
|
|
Absolute Value of Blast Count Before Treatment Line
LOT5-LOT7
|
30.8 Percentage of blast cells
Standard Deviation 35.2
|
14.7 Percentage of blast cells
Standard Deviation 35.9
|
PRIMARY outcome
Timeframe: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=367 Participants
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.
|
R/R B-cell ALL
n=42 Participants
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.
|
|---|---|---|
|
Absolute Value of Blast Count After Start of Treatment Line
LOT1
|
7.7 Percentage of blast cells
Standard Deviation 19.8
|
7.2 Percentage of blast cells
Standard Deviation 20.8
|
|
Absolute Value of Blast Count After Start of Treatment Line
LOT2
|
6.9 Percentage of blast cells
Standard Deviation 19.0
|
11.9 Percentage of blast cells
Standard Deviation 28.5
|
|
Absolute Value of Blast Count After Start of Treatment Line
LOT3
|
7.6 Percentage of blast cells
Standard Deviation 21.9
|
13.6 Percentage of blast cells
Standard Deviation 29.1
|
|
Absolute Value of Blast Count After Start of Treatment Line
LOT4
|
9.2 Percentage of blast cells
Standard Deviation 22.4
|
0.7 Percentage of blast cells
Standard Deviation 2.0
|
|
Absolute Value of Blast Count After Start of Treatment Line
LOT5-LOT7
|
13.0 Percentage of blast cells
Standard Deviation 23.0
|
0 Percentage of blast cells
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=471 Participants
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.
|
R/R B-cell ALL
n=59 Participants
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.
|
|---|---|---|
|
Absolute Value of Platelets Count Before Treatment Line
LOT1
|
68613 10^3 cells per microliter
Standard Deviation 75931
|
69220 10^3 cells per microliter
Standard Deviation 80225
|
|
Absolute Value of Platelets Count Before Treatment Line
LOT2
|
153362 10^3 cells per microliter
Standard Deviation 141776
|
115181 10^3 cells per microliter
Standard Deviation 110273
|
|
Absolute Value of Platelets Count Before Treatment Line
LOT3
|
112035 10^3 cells per microliter
Standard Deviation 120858
|
91565 10^3 cells per microliter
Standard Deviation 95696
|
|
Absolute Value of Platelets Count Before Treatment Line
LOT4
|
143263 10^3 cells per microliter
Standard Deviation 122895
|
69100 10^3 cells per microliter
Standard Deviation 96956
|
|
Absolute Value of Platelets Count Before Treatment Line
LOT5-LOT7
|
101231 10^3 cells per microliter
Standard Deviation 113248
|
77200 10^3 cells per microliter
Standard Deviation 60318
|
PRIMARY outcome
Timeframe: After start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Absolute value of platelet count after start of treatment according to different treatment lines were reported.
Outcome measures
| Measure |
Newly AML
n=415 Participants
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.
|
R/R B-cell ALL
n=55 Participants
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.
|
|---|---|---|
|
Absolute Value of Platelets Count After Start of Treatment Line
LOT1
|
105713 10^3 cells per microliter
Standard Deviation 153196
|
128894 10^3 cells per microliter
Standard Deviation 101555
|
|
Absolute Value of Platelets Count After Start of Treatment Line
LOT2
|
99613 10^3 cells per microliter
Standard Deviation 108309
|
78298 10^3 cells per microliter
Standard Deviation 79402
|
|
Absolute Value of Platelets Count After Start of Treatment Line
LOT3
|
75496 10^3 cells per microliter
Standard Deviation 77934
|
88996 10^3 cells per microliter
Standard Deviation 121220
|
|
Absolute Value of Platelets Count After Start of Treatment Line
LOT4
|
60340 10^3 cells per microliter
Standard Deviation 8533
|
39225 10^3 cells per microliter
Standard Deviation 12088
|
|
Absolute Value of Platelets Count After Start of Treatment Line
LOT5-LOT7
|
93184 10^3 cells per microliter
Standard Deviation 320836
|
71300 10^3 cells per microliter
Standard Deviation 75856
|
SECONDARY outcome
Timeframe: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=427 Participants
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.
|
R/R B-cell ALL
n=65 Participants
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.
|
|---|---|---|
|
Number of Participants With Molecular Test Performed
KGB
|
381 Participants
|
52 Participants
|
|
Number of Participants With Molecular Test Performed
FISH
|
112 Participants
|
31 Participants
|
|
Number of Participants With Molecular Test Performed
RT-PCR
|
247 Participants
|
40 Participants
|
|
Number of Participants With Molecular Test Performed
NGS
|
33 Participants
|
1 Participants
|
|
Number of Participants With Molecular Test Performed
ACGH
|
0 Participants
|
0 Participants
|
|
Number of Participants With Molecular Test Performed
Other
|
23 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to different AML translocation were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=319 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to AML Translocation Results: AML Arm Only
t(8;21)
|
22 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
inv(16)
|
26 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
der(11q23)
|
1 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
t(6;9)
|
1 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
t(1;22)
|
0 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
t(7;11)
|
1 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
inv(3)
|
4 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
t(16;21)
|
0 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
del(7q)
|
7 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
Monosomy 7(-7)
|
9 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
Complex cytogenetics/Complex karyotypes
|
40 Participants
|
—
|
|
Number of Participants According to AML Translocation Results: AML Arm Only
Other
|
208 Participants
|
—
|
SECONDARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to molecular profile were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=286 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Molecular Profile in Newly AML Arm
ASXL1
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
BCOR
|
2 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
CEBPA
|
13 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
CSF3R
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
DNMT3A
|
9 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
EZH2
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
IDH1
|
6 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
IDH2
|
3 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
KIT
|
8 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
KRAS
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
NPM1
|
66 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
NRAS
|
4 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
PTPN11
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
RUNX1
|
16 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
SF3B1
|
0 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
SRSF2
|
2 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
STAG2
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
TET2
|
4 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
TP53
|
5 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
U2AF1
|
0 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
ZRSR2
|
0 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
FLT3
|
94 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
MLL-PTD
|
3 Participants
|
—
|
|
Number of Participants According to Molecular Profile in Newly AML Arm
Other
|
125 Participants
|
—
|
SECONDARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to AML WHO classification were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=391 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with recurrent genetic abnormalities
|
28 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with t(8;21)(q22;q22.1);RUNX1
|
19 Participants
|
—
|
|
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
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
APL with PML
|
0 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with t(9;11)(p21.3;q23.3);MLLT3
|
2 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with t(6;9)(p23;q34.1);DEK
|
1 Participants
|
—
|
|
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
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML (megakaryoblastic) with t(1;22)(p13.3;q13.3);RBM15
|
0 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
Provisional entity: AML with BCR
|
0 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with mutated NPM1
|
36 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with biallelic mutations of CEBPA
|
3 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
Provisional entity: AML with mutated RUNX1
|
3 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML with myelodysplasia
|
27 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
Therapy
|
1 Participants
|
—
|
|
Number of Participants According to AML WHO Classification: AML Arm Only
AML, NOS
|
240 Participants
|
—
|
SECONDARY outcome
Timeframe: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to ALL WHO classification were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=56 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
B-lymphoblastic leukemia/lymphoma, NOS
|
30 Participants
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
B-lymphoblastic leukemia/lymphoma with hyperdiploidy
|
1 Participants
|
—
|
|
Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only
B-lymphoblastic leukemia/lymphoma with hypodiploidy
|
1 Participants
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=468 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
AML_IP_RES
|
7 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
cCD3
|
5 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
cCD79a
|
9 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
MPO
|
239 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD34
|
316 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD3
|
9 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD4
|
43 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD5
|
3 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD7
|
119 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD8
|
6 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
TdT
|
2 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD10
|
14 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD19
|
30 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD20
|
6 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD13
|
364 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD33
|
354 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD14
|
49 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD36
|
87 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
HLADR
|
376 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
glycophorin A
|
1 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD41
|
1 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD61
|
4 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
CD117
|
400 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for AML Arm Only
Other
|
327 Participants
|
—
|
SECONDARY outcome
Timeframe: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=20 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD19
|
18 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD20
|
6 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD22
|
11 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD79a
|
9 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
HLA Dr
|
6 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
TdT
|
7 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD10
|
17 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD34
|
18 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
CD45
|
11 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
Cytoplasmic IgM
|
1 Participants
|
—
|
|
Number of Participants According to Immunophenotyping Results for R/R B-cell ALL
Other
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of participants according to molecular profile in R/R B-cell ALL were reported.
Outcome measures
| Measure |
Newly AML
n=53 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
B-cell immunoglobulin gene rearrangement
|
1 Participants
|
—
|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
inv(16)
|
0 Participants
|
—
|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
der(11q23)
|
21 Participants
|
—
|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
t(6;9)
|
0 Participants
|
—
|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
t(4;11)
|
3 Participants
|
—
|
|
Number of Participants According to Molecular Profile in R/R B-cell ALL
Other
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=52 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
Good prognosis
|
1 Participants
|
—
|
|
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
Intermediate prognosis
|
16 Participants
|
—
|
|
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
Poor prognosis
|
29 Participants
|
—
|
|
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only
Undetermined prognosis
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=373 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
Favorable
|
85 Participants
|
—
|
|
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
Intermediate
|
179 Participants
|
—
|
|
Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)
Poor/Adverse
|
109 Participants
|
—
|
SECONDARY outcome
Timeframe: From the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=65 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=3 Participants
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.
|
R/R B-cell ALL
n=1 Participants
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.
|
|---|---|---|
|
Time From Start of First-Line Treatment to Start of the Adverse Event
|
56.0 Months
Standard Deviation 15.8
|
39.5 Months
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Number of clinical events were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=1220 clinical events
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.
|
R/R B-cell ALL
n=218 clinical events
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.
|
|---|---|---|
|
Number of Clinical Events
Hematological toxicities
|
317 Events
|
86 Events
|
|
Number of Clinical Events
Hepatotoxicity
|
5 Events
|
7 Events
|
|
Number of Clinical Events
Gastrointestinal toxicities
|
86 Events
|
17 Events
|
SECONDARY outcome
Timeframe: From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=508 Participants
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.
|
R/R B-cell ALL
n=79 Participants
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.
|
|---|---|---|
|
Event Free Survival (EFS)
|
1.5 Months
Interval 1.4 to 1.7
|
1.8 Months
Interval 1.4 to 2.7
|
SECONDARY outcome
Timeframe: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=517 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Overall Survival (OS)
|
10.6 Months
Interval 8.6 to 12.2
|
19.2 Months
Interval 15.4 to 32.0
|
SECONDARY outcome
Timeframe: 1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 monthsPopulation: 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.
Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=517 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
1 year
|
47.7 Percentage of participants
|
67.6 Percentage of participants
|
|
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
3 years
|
28.0 Percentage of participants
|
35.2 Percentage of participants
|
|
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation
5 years
|
24.5 Percentage of participants
|
19.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=383 Participants
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.
|
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.
|
|---|---|---|
|
Relapse Free Survival-Newly Diagnosed AML Participants Only
|
3.9 Months
Interval 3.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Newly AML
n=456 Participants
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.
|
R/R B-cell ALL
n=68 Participants
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.
|
|---|---|---|
|
Number of Participants According to Treatment Response
Complete remission-response (LOT1)
|
190 Participants
|
24 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response with incomplete hematological-count recovery (LOT1)
|
16 Participants
|
7 Participants
|
|
Number of Participants According to Treatment Response
Partial remission-response (LOT1)
|
27 Participants
|
5 Participants
|
|
Number of Participants According to Treatment Response
Progressive disease (LOT1)
|
33 Participants
|
9 Participants
|
|
Number of Participants According to Treatment Response
Refractory disease (LOT1)
|
142 Participants
|
19 Participants
|
|
Number of Participants According to Treatment Response
Relapsed from CR or CRi or recurrent disease (LOT1)
|
12 Participants
|
3 Participants
|
|
Number of Participants According to Treatment Response
Other (LOT1)
|
36 Participants
|
1 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response (LOT2)
|
129 Participants
|
12 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response with incomplete hematological-count recovery (LOT2)
|
11 Participants
|
5 Participants
|
|
Number of Participants According to Treatment Response
Partial remission-response (LOT2)
|
12 Participants
|
4 Participants
|
|
Number of Participants According to Treatment Response
Progressive disease (LOT2)
|
19 Participants
|
5 Participants
|
|
Number of Participants According to Treatment Response
Refractory disease (LOT2)
|
58 Participants
|
18 Participants
|
|
Number of Participants According to Treatment Response
Relapsed from CR or CRi or recurrent disease (LOT2)
|
14 Participants
|
2 Participants
|
|
Number of Participants According to Treatment Response
Other (LOT2)
|
16 Participants
|
3 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response (LOT3)
|
54 Participants
|
3 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response with incomplete hematological-count recovery (LOT3)
|
2 Participants
|
1 Participants
|
|
Number of Participants According to Treatment Response
Partial remission-response (LOT3)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Progressive disease (LOT3)
|
9 Participants
|
4 Participants
|
|
Number of Participants According to Treatment Response
Refractory disease (LOT3)
|
47 Participants
|
12 Participants
|
|
Number of Participants According to Treatment Response
Relapsed from CR or CRi or recurrent disease (LOT3)
|
8 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Other (LOT3)
|
11 Participants
|
5 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response (LOT4)
|
27 Participants
|
3 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response with incomplete hematological-count recovery (LOT4)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Partial remission-response (LOT4)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Progressive disease (LOT4)
|
6 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Refractory disease (LOT4)
|
18 Participants
|
5 Participants
|
|
Number of Participants According to Treatment Response
Relapsed from CR or CRi or recurrent disease (LOT4)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Other (LOT4)
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response (LOT5-LOT7)
|
8 Participants
|
4 Participants
|
|
Number of Participants According to Treatment Response
Complete remission-response with incomplete hematological-count recovery (LOT5-LOT7)
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Partial remission-response (LOT5-LOT7)
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Progressive disease (LOT5-LOT7)
|
3 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Refractory disease (LOT5-LOT7)
|
8 Participants
|
2 Participants
|
|
Number of Participants According to Treatment Response
Relapsed from CR or CRi or recurrent disease (LOT5-LOT7)
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Treatment Response
Other (LOT5-LOT7)
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Hospitalizations
|
880 Hospitalizations
|
128 Hospitalizations
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
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.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Reason for Hospitalization
ALL-AML Treatment
|
1064 Hospitalization
|
236 Hospitalization
|
|
Reason for Hospitalization
Adverse events
|
20 Hospitalization
|
4 Hospitalization
|
|
Reason for Hospitalization
Other
|
559 Hospitalization
|
134 Hospitalization
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Mean duration in intensive care unit were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=280 Participants
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.
|
R/R B-cell ALL
n=46 Participants
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.
|
|---|---|---|
|
Duration in Intensive Care Unit
|
9.1 Days
Standard Deviation 11.4
|
11.4 Days
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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.
Different clinical procedures were reported. One participant could have more than one procedure.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Procedures
Surgery
|
60 Procedures
|
8 Procedures
|
|
Number of Procedures
Image exams
|
1187 Procedures
|
172 Procedures
|
|
Number of Procedures
Laboratory exams
|
1494 Procedures
|
311 Procedures
|
|
Number of Procedures
Blood transfusions
|
1128 Procedures
|
162 Procedures
|
|
Number of Procedures
Associated treatments for infections
|
1062 Procedures
|
153 Procedures
|
|
Number of Procedures
Use of mechanical ventilation
|
141 Procedures
|
18 Procedures
|
|
Number of Procedures
Use of parenteral feeding
|
231 Procedures
|
11 Procedures
|
|
Number of Procedures
Other
|
70 Procedures
|
19 Procedures
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: 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 of participants according to type of surgery were reported in this outcome measure.
Outcome measures
| Measure |
Newly AML
n=60 Participants
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.
|
R/R B-cell ALL
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants According to Surgery
Abcess
|
9 Participants
|
0 Participants
|
|
Number of Participants According to Surgery
Catheter
|
2 Participants
|
2 Participants
|
|
Number of Participants According to Surgery
Tracheostomy
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Surgery
Other
|
45 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.
Outcome measures
| Measure |
Newly AML
n=518 Participants
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.
|
R/R B-cell ALL
n=71 Participants
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.
|
|---|---|---|
|
Number of Blood Transfusions
Platelet
|
1032 Blood transfusions
|
121 Blood transfusions
|
|
Number of Blood Transfusions
Plasma
|
107 Blood transfusions
|
16 Blood transfusions
|
|
Number of Blood Transfusions
Red blood cells
|
1051 Blood transfusions
|
139 Blood transfusions
|
|
Number of Blood Transfusions
Whole blood
|
63 Blood transfusions
|
4 Blood transfusions
|
|
Number of Blood Transfusions
Other
|
3 Blood transfusions
|
1 Blood transfusions
|
SECONDARY outcome
Timeframe: From diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 monthsPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.
Outcome measures
| Measure |
Newly AML
n=3343 concomitant medication
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.
|
R/R B-cell ALL
n=501 concomitant medication
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.
|
|---|---|---|
|
Number of Concomitant Medications
Vancomycin
|
268 Medications
|
36 Medications
|
|
Number of Concomitant Medications
Meropenem
|
252 Medications
|
34 Medications
|
|
Number of Concomitant Medications
Piperacillin; Tazobactam
|
219 Medications
|
36 Medications
|
|
Number of Concomitant Medications
Other
|
2604 Medications
|
395 Medications
|
Adverse Events
Newly AML
R/R B-cell ALL
Serious adverse events
| Measure |
Newly AML
n=518 participants at risk
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.
|
R/R B-cell ALL
n=71 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.39%
2/518 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Newly AML
n=518 participants at risk
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.
|
R/R B-cell ALL
n=71 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/518 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Vancomycin infusion reaction
|
0.19%
1/518 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
0.19%
1/518 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • From start of treatment until end of treatment, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER