Pancreatic Neuroendocrine Tumors
Conditions
Brief summary
This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.
Detailed description
The sunitinib non-interventional (NI) study is a real world observational study which represents the usual and customary treatment of patients and being proposed to collect data systematically and to assess the safety and efficacy in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.It is designed and conducted to meet CFDA post-marketing commitments. non-probability sample
Interventions
DRUGsunitinib
subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Subjects who are willing to follow up visits within current clinical practice. * Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification) * Unresectable (as assessed by the investigator) or metastatic disease documented on a scan * A minimum age of 18 years
Exclusion criteria
* Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification) * Patients who have received at least one dosage of sunitinib treatment prior to signing informed consent form will be excluded from participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product. The event did not necessarily need to have a causal relationship with the product treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. |
| Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | From baseline up to 8 years | An SAE was any untoward medical occurrence in a participant administered a medicinal at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. |
| Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | From baseline up to 8 years | Laboratory abnormalities assessment included: hematologic: hemoglobin, platelet count, white blood cell (WBC) count, neutrophile granulocyte count; non-hematologic: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transferase (GGT), total protein, albumin, blood urea nitrogen (BUN), creatinine, uric acid, glucose, hypocalcemia, hyponatremia, hypophosphatemia, hypokalaemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From baseline up to 8 years | Investigator assessed PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.6. PFS was defined as the time from the start of sunitinib treatment to first document of objective tumor progression or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Five-Year Survival Rate | From baseline up to 8 years | Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment. |
| Progression-Free Survival by Clinical Judgment | From baseline up to 8 years | PFS by clinical judgment was defined as the time from the start of sunitinib treatment to first document of objective tumor progression, or first time tumor progression diagnosed by investigator based on clinical judgment, or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Overall Survival (OS) | From baseline up to 8 years | OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause. |
Countries
China
Participant flow
Pre-assignment details
A total of 100 participants were enrolled and assigned to the study treatment, and 99 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib (Not Taken) Sunitinib (Not Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who would accept sunitinib therapy when signing informed consent. | 81 |
| Sunitinib (Already Taken) Sunitinib (Already Taken) were the participants with progressive, unresectable, advanced or metastatic well-differentiated pancreatic neuroendocrine tumors who had already taken sunitinib within the past 6 months (26 weeks) when signing informed consent and would continue sunitinib therapy. | 18 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 40 | 8 |
| Overall Study | Lost to Follow-up | 19 | 3 |
| Overall Study | Other | 15 | 3 |
| Overall Study | Participant refused further follow-up | 8 | 4 |
Baseline characteristics
| Characteristic | Sunitinib (Not Taken) | Sunitinib (Already Taken) | Total |
|---|---|---|---|
| Age, Continuous | 52.0 Years | 49.0 Years | 51.0 Years |
| Age, Customized 18-44 years | 26 Participants | 5 Participants | 31 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 years | 40 Participants | 11 Participants | 51 Participants |
| Age, Customized >=65 years | 15 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian | 81 Participants | 18 Participants | 99 Participants |
| Sex: Female, Male Female | 31 Participants | 6 Participants | 37 Participants |
| Sex: Female, Male Male | 50 Participants | 12 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 40 / 81 | 8 / 18 | 48 / 99 |
| other Total, other adverse events | 55 / 81 | 13 / 18 | 68 / 99 |
| serious Total, serious adverse events | 11 / 81 | 5 / 18 | 16 / 99 |
Outcome results
Primary
Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4
Laboratory abnormalities assessment included: hematologic: hemoglobin, platelet count, white blood cell (WBC) count, neutrophile granulocyte count; non-hematologic: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transferase (GGT), total protein, albumin, blood urea nitrogen (BUN), creatinine, uric acid, glucose, hypocalcemia, hyponatremia, hypophosphatemia, hypokalaemia.
Time frame: From baseline up to 8 years
Population: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. Participants with missing first dosing date were excluded from analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 0 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 2 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 2 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Alkaline phosphatase increased (Grade 0 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Alkaline phosphatase increased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 0 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | AST increased (Grade 1 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 0 to Grade 4) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Blood bilirubin increased (Grade 0 to Grade 3) | 3 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 0 to Grade 3) | 7 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Blood bilirubin increased (Grade 2 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 1 to Grade 4) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 1 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 2 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 2 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 0 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 0 to Grade 4) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hyperglycemia (Garde 0 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypocalcemia (Garde 0 to Grade 3) | 0 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 0 to Grade 3) | 4 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 1 to Grade 4) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 2 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 1 to Grade 4) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 2 to Grade 4) | 0 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 0 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hyponatremia (Garde 0 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypophosphatemia (Garde 0 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypophosphatemia (Garde 2 to Grade 3) | 2 Participants |
| Sunitinib (Not Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 0 to Grade 3) | 2 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypophosphatemia (Garde 2 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 0 to Grade 3) | 2 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Anemia (Grade 2 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 0 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Lymphocyte count decreased (Grade 2 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 0 to Grade 3) | 3 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Neutrophil count decreased (Grade 1 to Grade 4) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 0 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 0 to Grade 4) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Platelet count decreased (Grade 1 to Grade 4) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 0 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 1 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | WBC decreased (Grade 1 to Grade 4) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | ALT increased (Grade 2 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Alkaline phosphatase increased (Grade 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Alkaline phosphatase increased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | AST increased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Blood bilirubin increased (Grade 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Blood bilirubin increased (Grade 2 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 1 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 2 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | GGT increased (Grade 0 to Grade 4) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hyperglycemia (Garde 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypocalcemia (Garde 0 to Grade 3) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 2 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypokalemia (Garde 2 to Grade 4) | 1 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hyponatremia (Garde 0 to Grade 3) | 0 Participants |
| Sunitinib (Already Taken) | Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4 | Hypophosphatemia (Garde 0 to Grade 3) | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
An SAE was any untoward medical occurrence in a participant administered a medicinal at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
Time frame: From baseline up to 8 years
Population: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib (Not Taken) | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | All-causality SAEs | 11 Participants |
| Sunitinib (Not Taken) | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Treatment-related SAEs | 2 Participants |
| Sunitinib (Already Taken) | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | All-causality SAEs | 5 Participants |
| Sunitinib (Already Taken) | Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | Treatment-related SAEs | 2 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product. The event did not necessarily need to have a causal relationship with the product treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state.
Time frame: From baseline up to 8 years
Population: The safety analysis population included all enrolled participants who took at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib (Not Taken) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | All-causality TEAEs | 61 Participants |
| Sunitinib (Not Taken) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Treatment-related TEAEs | 52 Participants |
| Sunitinib (Already Taken) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | All-causality TEAEs | 13 Participants |
| Sunitinib (Already Taken) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) | Treatment-related TEAEs | 12 Participants |
Secondary
Five-Year Survival Rate
Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment.
Time frame: From baseline up to 8 years
Population: The analysis population included all participants who took at least 1 dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib (Not Taken) | Five-Year Survival Rate | 0.478 Proportion of participants |
| Sunitinib (Already Taken) | Five-Year Survival Rate | 0.504 Proportion of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause.
Time frame: From baseline up to 8 years
Population: The analysis population included all participants who took at least 1 dose of the study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib (Not Taken) | Overall Survival (OS) | 46.2 Months |
| Sunitinib (Already Taken) | Overall Survival (OS) | NA Months |
Secondary
Progression-Free Survival by Clinical Judgment
PFS by clinical judgment was defined as the time from the start of sunitinib treatment to first document of objective tumor progression, or first time tumor progression diagnosed by investigator based on clinical judgment, or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From baseline up to 8 years
Population: The analysis population included all participants who took at least 1 dose of the study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib (Not Taken) | Progression-Free Survival by Clinical Judgment | 10.4 Months |
| Sunitinib (Already Taken) | Progression-Free Survival by Clinical Judgment | 42.7 Months |
Secondary
Progression-Free Survival (PFS)
Investigator assessed PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.6. PFS was defined as the time from the start of sunitinib treatment to first document of objective tumor progression or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From baseline up to 8 years
Population: The analysis population included all participants who took at least 1 dose of the study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib (Not Taken) | Progression-Free Survival (PFS) | 10.4 Months |
| Sunitinib (Already Taken) | Progression-Free Survival (PFS) | 25.5 Months |