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To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)
All the patients prescribed according to approved indications at contracted institutions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate |
| |
| 2 | patients diagnosed as advanced RCC |
| |
| 3 | patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib malate | Drug | Sunitinib : dosing not pre-determined |
| |
| Sunitinib malate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no" (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST) | The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate or patients diagnosed as advanced RCC or patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Jung-gu | Daegu | 100-712 | South Korea | ||
| Daegu Catholic University Medical Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
This post marketing surveillance (PMS) study enrolled 520 participants between December 2007 and March 2015. Data from 100 participants were obtained from a previously completed study (A6181037).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sutene | Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Sunitinib : dosing not pre-determined |
|
| sunitinib malate | Drug | Sunitinib : dosing not pre-determined |
|
| At the end of study treatment, average of 23.2 weeks. |
| Nam-gu |
| Daegu |
| 705-718 |
| South Korea |
| GangNeung Asan Hospital | Gangneung-si | Gangwon-do | 210-711 | South Korea |
| Soonchunhyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 442-723 | South Korea |
| Seoul National University Hospital (SNUH) | Seoul | Seoul | 110-744 | South Korea |
| Hwasun Hospital, Chonnam National University | Cheonnam | South Jeolla Province | 519-809 | South Korea |
| Hallym University Sacred Heart Hospital | Anyang | 431-070 | South Korea |
| Pusan National University Hospital | Busan | 602 739 | South Korea |
| Kosin University Gospel Hospital | Busan | 602-702 | South Korea |
| Dong-A University Hospital | Busan | 602-715 | South Korea |
| Dong-A University Medical Center (Dong-A University Hospital) | Busan | 602-715 | South Korea |
| Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology | Busan | 602-715 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Hwasun Hospital, Chonnam National University | Cheonnam | 519-809 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 700 712 | South Korea |
| Kyungpook National University Medical Center | Daegu | 702-210 | South Korea |
| Daegu Catholic University Medical Center (DCUMC) | Daegu | 705-718 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang | 411-706 | South Korea |
| Chosun University Hospital | Gwang Joo | 501-717 | South Korea |
| Pusan National University Hospital | Gyeongsangnam-do | 626-770 | South Korea |
| Wonkwang University School of Medicine and Hospital (WUH) | Iksan -Si | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Yeungnam University Medical Center | Nam-gu | 705-717 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital / Department of Internal Medicine | Seoul | 110-744 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Kyung Hee University Medical Center | Seoul | 130-872 | South Korea |
| KyungHee University Medical Center | Seoul | 130-872 | South Korea |
| Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology | Seoul | 135-710 | South Korea |
| Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine | Seoul | 135-710 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 135-720 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Asan Medical Center/Department of Oncology | Seoul | 138-736 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Korea Cancer Center Hospital | Seoul | 139-706 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-710 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Seoul ST. Mary's Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| Yonsei University Wonju College of Medicine, Wonju Christian Hospital | Wŏnju | 220-701 | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: Participants who administered Sutene at least once and were evaluated upon its related safety endpoints at least once.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sutene | Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Gender | Count of Participants | Participants |
| |||||||||||||||||||||||
| Diagnosis | 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 | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs | An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no" (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. | Safety Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks. |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST) | The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. | Intent-to-treat Analysis Set: Participants who administered Sutene at least once. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At the end of study treatment, average of 23.2 weeks. |
|
From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
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 | Sutene | Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 72 | 617 | 474 | 617 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Ascites | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Asthenia | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Death | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fatigue | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fever | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Oedema | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pain | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Circulatory failure | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Convulsions | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| hypothyroidism | Endocrine disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Abdomen enlarged | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Appendicitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemorrhage rectum | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hiccup | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Bilirubinaemia | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Carcinoma of oesophagus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Gastric carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pulmonary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART version 092 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Purpura thrombopenic thrombotic | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Mental deficiency | Psychiatric disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemolytic-uraemic syndrome | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | WHO-ART version 092 | Non-systematic Assessment |
| |
| Shock septic | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | WHO-ART version 092 | Non-systematic Assessment |
| |
| Post-operative wound infection | Injury, poisoning and procedural complications | WHO-ART version 092 | Non-systematic Assessment |
| |
| Surgical intervention | Surgical and medical procedures | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Haemorrhage nos | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thromboembolism | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombophlebitis deep | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Asthenia | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Chest pain | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Face oedema | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fatigue | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Fever | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Oedema | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Oedema periorbital | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia | General disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Mucositis nos | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamic-oxaloacetic transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Serum glutamate pyruvate transaminase increased | Hepatobiliary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Coughing | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Leucopenia | Blood and lymphatic system disorders | WHO-ART version 092 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@Pfizer.com |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| 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
| Progressive Pancreatic Neuroendocrine Carcinoma |
|
| Data Missing |
|
| Title | Measurements |
|---|---|
|
| SADRs |
|
| Unexpected AEs |
|
| Unexpected ADRs |
|
| Unexpected SAEs |
|
| Unexpected SADRs |
|
| Units | Counts |
|---|---|
| Participants |
|
|