Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis |
Socio-demographic variables included will include categories of Age (in years), Sex (male and female), and US geographic region. |
Baseline (Day 1) |
|
Primary |
Number of CML Participants With Baseline Clinical Characteristics of Disease Severity |
|
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Quan-Charlson Comorbidity Index Score |
The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity. |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Number of CML Participants With Baseline Clinical Characteristics of Comorbidities |
Comorbidities will include anemia, diabetes, chronic pulmonary disease, congestive heart failure, hypertension, hypercholesterolemia, obesity, renal disease, moderate to severe liver disease, dementia, acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV). |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Number of CML Participants With Baseline Clinical Characteristics of Concomitant Medication |
Concomitant medication will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta blockers and statins) and antidiabetic drugs (metformin, sulfonylurea, thiazolidinedione, insulin and other antidiabetic drugs). |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Number of Previous Treatments of Tyrosine Kinase Inhibitors (TKI) Drugs in Participants with CML |
The number of TKI drugs used prior to the index date will be identified. The type of the 1^st and 2^nd TKI drugs will be identified. |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Duration Between Last TKI Run-out Date to the Index Date for Participants with CML |
Time from the run-out date of the last prescription to the index date will be calculated. If the run-out date passed the index date, the gap will be counted as 0. |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Number of Participants with Bone Marrow Stem Cell Transplant |
|
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs) |
MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as pulmonary embolism (PE) and deep vein thrombosis (DVT). |
Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 |
|
Primary |
Treatment Patterns Based on Duration of Index Treatment |
Time from the first prescription of the index drug to the run-out date of the last prescription of the index drug, or 1 day before a new TKI prescription date, whichever occurred earlier. |
Up to approximately 5 years |
|
Secondary |
Number of Participants With BCR-ABL and Bone Marrow Testing |
BCR-ABL test will include participants tested for BCR-ABL mutation, such as T315I, and participants with a diagnostic marrow test. |
Up to approximately 5 years |
|
Secondary |
Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML |
The mean daily and average dose of the first prescription in the treatment line will be calculated. The starting and average daily dose will be classified as low, standard, and high for each drug cohort. |
Up to approximately 5 years |
|
Secondary |
Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21 |
The disease severity will include categories of low, moderate, and high severity. |
Up to approximately 5 years |
|
Secondary |
Treatment Patterns Based on Number of Participants With CML on Concomitant Medication |
The concomitant medications will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs. |
Up to approximately 5 years |
|
Secondary |
Number of Participants With CML With Treatment-Free Gap of the Index Treatment |
|
Up to approximately 5 years |
|
Secondary |
Disease Progression |
Disease progression will be defined as having a change of disease severity from low severity in the baseline period to moderate or high severity in the current line, or from moderate severity in the baseline period to high severity in the current line OR a change in TKI type, addition of chemotherapy agents, or allogeneic stem cell transplant procedure OR mortality. |
Up to approximately 5 years |
|
Secondary |
Percentage of CML Participants With Complications |
|
Up to approximately 5 years |
|
Secondary |
Overall Survival (OS) |
OS is defined as the interval between the first does of study treatment and death due to any cause, censored at the last contact date when the participant was alive. |
Up to approximately 5 years |
|
Secondary |
Progression Free Survival (PFS) |
PFS is defined as the time in days from the index date to the first observed disease progression. |
Up to approximately 5 years |
|
Secondary |
Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs) |
AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with the treatment. MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as PE and DVT. |
Up to approximately 5 years |
|