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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018585-23 | EudraCT Number |
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The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axitinib (AG-013736) | Drug | axitinib will be given at a starting dose of 5 mg BID with continuous dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS): First-Line Participants | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| Progression Free Survival (PFS): Second-Line Participants | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response (OR): First-Line Participants | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Medical Specialties | Miami | Florida | 33143 | United States | ||
| Advanced Medical Specialties |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526095 | Derived | Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1. | |
| 37146227 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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All China participants were excluded from safety analysis due to inability to obtain timely approval to use data in accordance with Human Genetic Resources Administration of China (HGRAC) regulation.
First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Axitinib (First-line Participants) | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sorafenib | Drug | sorafenib will be given at a dose of 400 mg BID continuous dosing |
|
| Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| Percentage of Participants With Objective Response (OR): Second-Line Participants | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| Duration of Response (DR): First-Line Participants | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| Duration of Response (DR): Second-Line Participants | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| Overall Survival (OS): First-Line Participants | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| Overall Survival (OS): Second-Line Participants | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| Miami |
| Florida |
| 33176 |
| United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Indiana University Health Central Indiana Cancer Centers | Carmel | Indiana | 46032 | United States |
| Indiana University Health Central Indiana Cancer Centers | Fishers | Indiana | 46037 | United States |
| Indiana University Health Central Indiana Cancer Centers | Greenfield | Indiana | 46140 | United States |
| Indiana University Health Central Indiana Cancer Centers | Indianapolis | Indiana | 46219 | United States |
| Indiana University Health Central Indiana Cancer Centers | Indianapolis | Indiana | 46227 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| US Oncology West Region | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey | 07962 | United States |
| Hematology-Oncology Associates of Northern NJ, PA | Parsippany | New Jersey | 07054 | United States |
| New York Oncology Hematology, PC | Albany | New York | 12206 | United States |
| New York Oncology Hematology, PC | Albany | New York | 12208 | United States |
| New York Oncology Hematology, PC | Latham | New York | 12110 | United States |
| New York Oncology Hematology, PC | Rexford | New York | 12148 | United States |
| New York Oncology Hematology, PC | Troy | New York | 12180 | United States |
| Raleigh Hematology Oncology Associates | Cary | North Carolina | 27518 | United States |
| Raleigh Hematology Oncology Associates | Raleigh | North Carolina | 27607 | United States |
| Raleigh Hematology Oncology Associates | Raleigh | North Carolina | 27614 | United States |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97213 | United States |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97225 | United States |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97227 | United States |
| Northwest Cancer Specialists, PC | Tualatin | Oregon | 97062 | United States |
| Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute | Hershey | Pennsylvania | 17033-0850 | United States |
| Medical University of South Carolina University Hospital | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Oncology- Amarillo | Amarillo | Texas | 79106 | United States |
| Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont | Texas | 77702-1449 | United States |
| Texas Oncology- Bedford | Bedford | Texas | 76022 | United States |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology- Fort Worth 12th Avenue | Fort Worth | Texas | 76104 | United States |
| Texas Oncology- Southwest Fort Worth | Fort Worth | Texas | 76132 | United States |
| Investigational Products Center (lPC) | Fort Worth | Texas | 76177 | United States |
| US Oncology Research and Clinical Pharmacy | Fort Worth | Texas | 76177 | United States |
| Texas Oncology - Grapevine | Grapevine | Texas | 76051 | United States |
| Cancer Care Centers of South Texas | Kerrville | Texas | 78028 | United States |
| Texas Oncology- McAllen South Second Street | McAllen | Texas | 78503 | United States |
| Texas Oncology- Midland Allison Cancer Center | Midland | Texas | 79701 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78258-3912 | United States |
| Texas Oncology-Deke Slayton Cancer Center | Webster | Texas | 77598-4420 | United States |
| Texas Oncology-Weslaco | Weslaco | Texas | 78596 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Christiansburg | Virginia | 24073 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Low Moor | Virginia | 24457 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Wytheville | Virginia | 24382 | United States |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98684 | United States |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98686 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | United States |
| Clinic of Oncology | Banja Luka | 78000 | Bosnia and Herzegovina |
| Institute of Oncology, University Hospital Center Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy | Tuzla | 75000 | Bosnia and Herzegovina |
| Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya | Sofia | 1756 | Bulgaria |
| SBALOZ D-r Marko Markov-Varna | Varna | 9000 | Bulgaria |
| Instituto Clinico Oncologico del Sur | Temuco | Araucania | 4810561 | Chile |
| Instituto Clinico Oncologico del Sur | Temuco | Cautin | 4810469 | Chile |
| Instituto de Terapias Oncologicas Providencia | Providencia | Santiago Metropolitan | 7501088 | Chile |
| Private Office | Santiago | RM 8360160 | Chile |
| Cancer Institute and Hospital ,Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Chinese PLA General Hospital | Haidian District | Beijing Municipality | 100853 | China |
| The Fuzhou General Hospital, PLA Nanjing Military Area Command | Fuzhou | Fujian | 350025 | China |
| Urology Department, Sun Yet-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| Nanjing Bayi Hospital | Nanjing | Jiangsu | 210002 | China |
| The Oncology Department, Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Jilin Provincial Cancer Hospital | Changchun | Jilin | 130012 | China |
| Urology Department, 1st Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Xijing Hospital, The Fourth Military Medical University,Oncology Department | Xi'an | Shaanxi | 710032 | China |
| Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology | Hangzhou | Zhejiang | 310016 | China |
| Department of Urology,Peking University First Hospital | Beijing | 100034 | China |
| Beijing Cancer Hospital/Department of Renal Cancer and Melanoma | Beijing | 100036 | China |
| South-Western Hospital, 3rd Military Medical University | Chongqing | 400038 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Fudan University, Cancer Hospital, Department of Urology | Shanghai | 200032 | China |
| Tianjin Oncology Hospital,biology treatment department | Tianjin | 300060 | China |
| Urology Department, The Second Hospital of Tianjin Medical University | Tianjin | 300211 | China |
| BIBI General Hospital and Cancer Centre, | Hyderabad | Andhra Pradesh | 500024 | India |
| Chinmaya Mission Hospital | Bangalore | Karnataka | 560038 | India |
| Sri Venkateshwara Hospital | Bangalore | Karnataka | 560068 | India |
| NU Hospitals | Bangalore | Karnataka | 560070 | India |
| Cancer Care Clinic and Hospitals | Nagpur | Maharashtra | 440012 | India |
| Shatabdi Superspeciality Hospital | Nashik | Maharashtra | 422 005 | India |
| Curie Manavata Cancer Centre | Nashik | Maharashtra | 422004 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | 411 004 | India |
| Sahyadri Speciality Hospital | Pune | Maharashtra | 411 004 | India |
| Shettys hospital | Bangalore | 560068 | India |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital General de Mexico O.D. | Mexico City | Mexico City | 06726 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | Mexico City | 14000 | Mexico |
| Centro Hemato-Oncologico Privado | Toluca | State of Mexico | 50080 | Mexico |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20000 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute | Quezon City | Diliman | Philippines |
| St. Lukes Medical Center | Quezon City | National Capital Region | 1102 | Philippines |
| University of the East Ramon Magsaysay Memorial Medical Center | Quezon City | National Capital Region | 1113 | Philippines |
| Makati Medical Center | Makati City | 1200 | Philippines |
| Room 805, Committee on Research Room, Manila Doctors Hospital | Manila | 1000 | Philippines |
| Oncomed SRL | Timișoara | JUD. Timis | 300239 | Romania |
| Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca | Cluj-Napoca | 400015 | Romania |
| GBU RO "Ryazan Regional Clinical Oncology Dispensary" | Ryazan | Russian Federation | 390011 | Russia |
| FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov" | Ryazan | Russian Federation | 390026 | Russia |
| Moscow State Healthcare Institution Oncology Clinical Dispensary #1 | Moscow | 105005 | Russia |
| P.A. Herzen Moscow Oncology Research Institute, | Moscow | 125284 | Russia |
| FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov" | Saint Petersburg | 197022 | Russia |
| Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic | Ufa | 450054 | Russia |
| GVI Oncology | Port Elizabeth | 6045 | South Africa |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady, | Dnipro | 49005 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr | Kharkiv | 61037 | Ukraine |
| DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi | Kyiv | 03115 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi | Lviv | 79031 | Ukraine |
| SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine" | Zaporizhzhya | 69040 | Ukraine |
| Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2. |
| 33947608 | Derived | Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5. |
| 28410911 | Derived | de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21. |
| 27498023 | Derived | Hutson TE, Al-Shukri S, Stus VP, Lipatov ON, Shparyk Y, Bair AH, Rosbrook B, Andrews GI, Vogelzang NJ. Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial. Clin Genitourin Cancer. 2017 Feb;15(1):72-76. doi: 10.1016/j.clgc.2016.05.008. Epub 2016 May 27. |
| 27238653 | Derived | Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26. |
| 26089686 | Derived | Qin S, Bi F, Jin J, Cheng Y, Guo J, Ren X, Huang Y, Tarazi J, Tang J, Chen C, Kim S, Ye D. Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study. Onco Targets Ther. 2015 Jun 8;8:1363-73. doi: 10.2147/OTT.S83302. eCollection 2015. |
| 24206640 | Derived | Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1287-94. doi: 10.1016/S1470-2045(13)70465-0. Epub 2013 Oct 25. |
| Sorafenib (First-line Participants) |
Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| FG002 | Axitinib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| FG003 | Sorafenib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| Treated |
|
| Participants From China (Excluded From Safety Analysis) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib (First-line Participants) | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| BG001 | Sorafenib (First-line Participants) | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| BG002 | Axitinib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| BG003 | Sorafenib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
| BG004 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Progression Free Survival (PFS): First-Line Participants | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS): Second-Line Participants | Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. | FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (OR): First-Line Participants | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (OR): Second-Line Participants | Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR): First-Line Participants | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR). | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR): Second-Line Participants | Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR). | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS): First-Line Participants | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS): Second-Line Participants | Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). | FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants | FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate). | FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). | FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants | FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate). | FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. | FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state. | FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) |
|
Not provided
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
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 | Axitinib (First-line Participants) | Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 117 | 173 | 77 | 173 | 161 | 173 |
| EG001 | Sorafenib (First-line Participants) | Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 63 | 88 | 26 | 88 | 83 | 88 |
| EG002 | Axitinib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 9 | 11 | 6 | 11 | 11 | 11 |
| EG003 | Sorafenib (Second-line Participants) | Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. | 3 | 5 | 3 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Axonal and demyelinating polyneuropathy | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cardiac neoplasm unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemorrhoid infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tri-iodothyronine free decreased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anisocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Macrocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Polychromasia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Mucosal excoriation | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Anal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.1 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Haemostasis | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
|
The objective of the statistical analysis for secondary endpoints was to summarize data using descriptive statistics without performing any hypothesis testing. Safety analysis did not include data from all China participants due to inability to obtain timely approval to use data in accordance to HGRAC regulations.
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 |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077784 | Axitinib |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
Not provided
Not provided
| Greater than or equal to (>=) 65 years |
|
| Male |
|
Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
|
Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
|
|
Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
|
|
|
|
|
|
|
|
Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
|
|
Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
| Sorafenib (Second-line Participants) |
Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks. |
|
|
|
|
|
|