Trial Outcomes & Findings for Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database (NCT NCT05286528)
NCT ID: NCT05286528
Last Updated: 2023-10-27
Results Overview
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
COMPLETED
1484 participants
5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
2023-10-27
Participant Flow
Data of participants, who received tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) anytime from 01 January 2009 to 30 June 2020, under the terms of the current marketing authorization, inclusion criteria, for treatment of chronic myeloid leukemia (CML), was retrieved from database National Health Insurance Fund (NHIF) of Hungary.
Participant milestones
| Measure |
Participants With CML
Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011.
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|---|---|
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Overall Study
STARTED
|
1484
|
|
Overall Study
COMPLETED
|
1484
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants With CML
n=1484 Participants
Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011.
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|---|---|
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Age, Continuous
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56.14 Years
STANDARD_DEVIATION 17.13 • n=1484 Participants
|
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Sex: Female, Male
Female
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704 Participants
n=1484 Participants
|
|
Sex: Female, Male
Male
|
780 Participants
n=1484 Participants
|
PRIMARY outcome
Timeframe: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)Population: Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020.
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Outcome measures
| Measure |
Participants With CML
n=1484 Participants
Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011.
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|---|---|
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Overall Survival Rate: All Participants
|
77.1 Percentage of participants
|
PRIMARY outcome
Timeframe: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)Population: Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020.
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Outcome measures
| Measure |
Participants With CML
n=1484 Participants
Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011.
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|---|---|
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Overall Survival Rate: Type of First Line TKI
|
77.1 Percentage of participants
|
PRIMARY outcome
Timeframe: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)Population: Analysis set included all participants initiated with second line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020. Here, Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Outcome measures
| Measure |
Participants With CML
n=647 Participants
Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011.
|
|---|---|
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Overall Survival Rate: Type of Second Line TKI
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71.5 Percentage of participants
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PRIMARY outcome
Timeframe: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)Population: NHIF did not provide data for event below 10 participants. Apart from 2 sequences all rest sequences had low yearly participants during the whole studied period (less than 10 participants). Hence data for analysis for Overall Survival rate by sequence was not collected and analyzed for whole population.
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Outcome measures
Outcome data not reported
Adverse Events
Participants With CML
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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