Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Progression Free Survival (PFS) |
The PFS will be calculated as the time (months) from the index date to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. |
From the index date (treatment start date) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first (up to 5.5 years) |
|
| Secondary |
Overall Survival (OS) |
The OS is defined as time from index date (treatment start date) to death by any cause during the study follow-up period. |
From index date (treatment start date) to death by any cause during the study follow-up period (up to 5.5 years) |
|
| Secondary |
Number of Participants Stratified by Vital Status on Last Follow up Visit |
Latest information about participants vital status (alive, death, lost of follow-up) will be reported. |
Up to approximately 5 years (Follow-up Period) |
|
| Secondary |
Number of Deaths and Cause of Deaths |
Number of deaths and different cause of deaths will be reported. |
Up to approximately 5.5 years |
|
| Secondary |
Time to Next Treatment (TTNT) |
The TTNT is defined as interval from the date of initiation of a treatment to the date of commencement of the next line of therapy. |
From the date of initiation of a treatment to the date of commencement of the next line of therapy (up to 5.5 years) |
|
| Secondary |
Treatment-Free-Interval (TFI) |
The TFI is defined as interval between the end of one regimen and the start of the next regimen (death or the end of follow-up are censoring events). |
Up to approximately 5.5 years |
|
| Secondary |
Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period |
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. |
Up to approximately 5 years (Follow-up Period) |
|
| Secondary |
Number of Participants With Adverse Events (AEs) During follow-up Period |
An adverse event (AE) is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product (including peripheral neuropathy and neutropenia). |
Up to approximately 5 years (Follow-up Period) |
|
| Secondary |
Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period |
An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. |
Up to approximately 5 years (Follow-up Period) |
|
| Secondary |
Number of Participants With Most Common SAEs and Total AEs During Follow-up Period |
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Most common SAEs are defined as most frequent SAEs occurred during the study. An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. |
Up to approximately 5 years (Follow-up Period) |
|
| Secondary |
Number of Treatment Cycles Participants Received |
Number of treatment cycles received by participants will be reported. The length of each treatment cycle will be 28 days. |
Up to approximately 6 months |
|
| Secondary |
Percentage of Participants With Completed Treatment Cycles |
Participant who completed 6 cycles of treatment during the treatment window (July 1, 2017, to December 31, 2020) will be considered completed. The length of each treatment cycle will be 28 days. |
Up to approximately 6 months |
|
| Secondary |
Number of Participants With Treatment Interruption and Main Reasons |
Number of participant's that interrupted their treatment and the main reason will be reported. Reasons includes economical (example, healthcare insurance issues, cost-related, access barriers, etc.), participant's decision, adverse event (including toxicity), diseases progression, medical decision, death, other. |
Up to approximately 6 months |
|
| Secondary |
Number of Participants With Comorbidities and Comorbidities per Type |
Comorbidities may include diabetes, obesity, autoimmune disease (example, arthritis, lupus and others), infectious disease (example, human immunodeficiency virus, Epstein Barr virus), cardiovascular disease (example, congestive heart failure, rhythm abnormalities, hypertension), dyslipidemia, cerebrovascular disease, gastrointestinal disease (example, gastritis, ulcer), pulmonary disease (example, chronic pulmonary disease, chronic obstructive disease), liver disease, renal disease, thyroid disease, depression, neurologic (example neuropathies), other cancers, and others. |
Up to approximately 5.5 years |
|
