Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunitinib group | patients with progressive, unresectable, advanced or metastatic well-differentiated pNET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline up to 8 years |
| 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. | From baseline up to 8 years |
| 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. | From baseline up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department, The Second Affiliated Hospital of Anhui Medical University | Hefei | An'hui | 230061 | China | ||
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
A total of 100 participants were enrolled and assigned to the study treatment, and 99 participants were treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sunitinib (Already Taken) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2015 | Nov 22, 2023 |
Not provided
Not provided
Not provided
Not provided
| From baseline up to 8 years |
| 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. | From baseline up to 8 years |
| Overall Survival (OS) | OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause. | From baseline up to 8 years |
| 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. | From baseline up to 8 years |
| Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| SUN Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| The Affiliated Tumour Hospital of Harbin Medical University | Haerbin | Heilongjiang | 150081 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Eastern Theater General Hospital,QinHuai District Medical Area | Nanjing | Jiangsu | 210002 | China |
| General Hospital of Eastern Theater Command | Nanjing | Jiangsu | 210002 | China |
| Nanjing Bayi Hospital | Nanjing | Jiangsu | 210002 | China |
| Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department | Nanjing | Jiangsu | 210002 | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University | Xi'an | Shannxi | 710032 | China |
| The First Affiliated Hospital，Air Force Medical University | Xi'an | Shannxi | 710032 | China |
| Air Force Medical University | Xi’an | Shanxi | China |
| West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery | Chengdu | Sichuan | 610041 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Zhejiang Cancer Hospital, Oncology department | Hangzhou | Zhejiang | 310022 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Fifth Medical Center of PLA General Hospital | Beijing | 100071 | China |
| The PLA of 307 Hospital | Beijing | 100071 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Tianjin Medical University General Hospital/General Surgery | Tianjin | 300052 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
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. |
| Treated | One participant (not taken sunitinib before) who had been assigned to the study treatment was not treated and therefore excluded from the study analysis. |
|
| Discontinued | Discontinued participants included those who completed minimum 5-year follow-up since they have been assigned to the study treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis population included all enrolled participants who took at least 1 dose of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. | Posted | Count of Participants | Participants | From baseline up to 8 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | The safety analysis population included all enrolled participants who took at least 1 dose of the study drug. | Posted | Count of Participants | Participants | From baseline up to 8 years |
| ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to 8 years |
| ||||||||||||||||||||||||||||||||||||||
| 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. | The analysis population included all participants who took at least 1 dose of the study drug. | Posted | Median | 95% Confidence Interval | Months | From baseline up to 8 years |
| |||||||||||||||||||||||||||||||||||||
| 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. | The analysis population included all participants who took at least 1 dose of the study drug. | Posted | Median | 95% Confidence Interval | Months | From baseline up to 8 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause. | The analysis population included all participants who took at least 1 dose of the study drug. | Posted | Median | 95% Confidence Interval | Months | From baseline up to 8 years |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | The analysis population included all participants who took at least 1 dose of the study drug. | Posted | Number | 95% Confidence Interval | Proportion of participants | From baseline up to 8 years |
|
|
From baseline up to 8 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 40 | 81 | 11 | 81 | 55 | 81 |
| EG001 | 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. | 8 | 18 | 5 | 18 | 13 | 18 |
| EG002 | Total | (=sum per row) | 48 | 99 | 16 | 99 | 68 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v25.1 | Non-systematic Assessment | 2 cases were reported with AE term as Death.The AE term for 1 participant was "unknown cause of death".Death reason for the other one was disease progression.So data here was updated to 1.The other one was added to SAE of Disease progression below. |
|
| Disease progression | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Portal vein embolisation | Surgical and medical procedures | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
Due to the real world nature of this study, heterogeneity of clinical judgment and clinical practice may exist which may include but it not limited to the following: timing of imaging/laboratory testing, different measurement techniques/standards for judging tumor change.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2018 | Nov 22, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 18-44 years |
|
| 45-64 years |
|
| >=65 years |
|
| Male |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|