Not provided
Not provided
Not provided
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Primary endpoint did not reach statistical significance
Not provided
Not provided
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| SFJ Pharmaceuticals, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.
This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.
Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axitinib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axitinib | Drug | Axitinib 5 mg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC) | DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan. | From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization. | From randomization date until death due to any cause (up to 5 years) |
Not provided
Inclusion Criteria:
Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Patients must have no evidence of macroscopic residual disease or metastatic disease.
Male or female, age >=18 years (age >=20 years in Japan, Korea and Taiwan).
Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):
Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
Patients must not have received any previous anti angiogenic treatment.
Patients must have adequate organ function.
Exclusion Criteria
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92093 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30346481 | Derived | Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454. |
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A total of 128 study sites in 9 countries randomized 724 participants into this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Axitinib | Participants at high risk of recurrent renal cell carcinoma (RCC) received Axitinib 5 milligram (mg) twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2018 | Apr 22, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo twice daily |
|
| Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs) | A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events. | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology | Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry | Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Laboratory Abnormalities: Thyroid Function | Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported. | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Number of Participants With Laboratory Abnormalities: Urinalysis | Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported. | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Palo Alto | California | 94304 | United States |
| Pleasant Hill | California | 94523 | United States |
| Denver | Colorado | 80218 | United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Ocala | Florida | 34471 | United States |
| Atlanta | Georgia | 30322 | United States |
| Annapolis | Maryland | 21403 | United States |
| Baltimore | Maryland | 21231-1000 | United States |
| Saint Paul | Minnesota | 55118 | United States |
| Omaha | Nebraska | 68198 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Albany | New York | 12208 | United States |
| New York | New York | 10467 | United States |
| Portland | Oregon | 97227 | United States |
| Charleston | South Carolina | 29412 | United States |
| Chattanooga | Tennessee | 37421 | United States |
| Austin | Texas | 78731 | United States |
| Bedford | Texas | 76022 | United States |
| Dallas | Texas | 75203 | United States |
| Houston | Texas | 77024 | United States |
| San Antonio | Texas | 78217 | United States |
| San Antonio | Texas | 78234 | United States |
| Norfolk | Virginia | 23502 | United States |
| Seattle | Washington | 95109 | United States |
| Beijing | China |
| Changchun | China |
| Chongqing | China |
| Dalian | China |
| Guangzhou | China |
| Hangzhou | China |
| Jinan | China |
| Nanchang | China |
| Shanghai | China |
| Suzhou | China |
| Tianjin | China |
| Wuhan | China |
| Besançon | France |
| Bordeaux | France |
| Hyères | France |
| Le Mans | France |
| Lyon | France |
| Marseille | France |
| Paris | France |
| Rennes | France |
| Saint-Herblain | France |
| Suresnes | France |
| Vandœuvre-lès-Nancy | France |
| Hong Kong | Hong Kong |
| Ahmeadbad | India |
| Aurangabad | India |
| Bangalore | India |
| Chennai | India |
| Hyderabad | India |
| Karamsad | India |
| Kochi | India |
| Kolkota | India |
| Lucknow | India |
| Ludhiana | India |
| Mangalore | India |
| Manipal | India |
| Mumbai | India |
| Nashik | India |
| New Delhi | India |
| Pune | India |
| Surat | India |
| Visakhapatnam | India |
| Aichi | Japan |
| Akita | Japan |
| Aomori | Japan |
| Chiba | Japan |
| Fukuoka | Japan |
| Gifu | Japan |
| Hokkaido | Japan |
| Hyōgo | Japan |
| Kagawa | Japan |
| Kanagawa | Japan |
| Kumamoto | Japan |
| Kyoto | Japan |
| Nagasaki | Japan |
| Nigata-honmachi | Japan |
| Osaka | Japan |
| Shizuoka | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
| Yamagata | Japan |
| Yamaguchi | Japan |
| Busan | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Gyeonggi-do | South Korea |
| Jeonnam | South Korea |
| Seoul | South Korea |
| Barcelona | Spain |
| Donostia / San Sebastian | Spain |
| Leganés | Spain |
| Llobregat | Spain |
| Madrid | Spain |
| Oviedo | Spain |
| Seville | Spain |
| Valencia | Spain |
| Zaragoza | Spain |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| FG001 |
| Placebo |
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axitinib | Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. . |
| BG001 | Placebo | Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI | Categorization of participants on body mass index (BMI): Normal (18.5 less than or equal to [<=] BMI less than [<] 25), Overweight + Obese (BMI greater than or equal to [>=] 25), Overweight (25<=BMI<30), Obese (BMI>=30) and Underweight (BMI<18.5). | 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 | Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC) | DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan. | ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment. | Posted | Median | 95% Confidence Interval | years | From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization. | ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment. | Posted | Median | 95% Confidence Interval | years | From randomization date until death due to any cause (up to 5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs) | A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events. | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology | Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry | Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities: Thyroid Function | Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported. | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities: Urinalysis | Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported. | As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after last dose (maximum duration of 3 years) |
|
From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Same event may appear as both an AE and 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. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment 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 | Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. | 31 | 360 | 75 | 360 | 353 | 360 |
| EG001 | Placebo | Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. | 33 | 360 | 54 | 360 | 332 | 360 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Stress Cardiomyopathy | Cardiac disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Retinal Haemorrhage | Eye disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Intestinal Polyp | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Large Intestinal Stenosis | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Oesophageal Disorder | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pancreatic Cyst | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cholangitis Acute | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Livery Injury | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Diarrhoea Infectious | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Otitis Media Chronic | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Ligament Injury | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Snake Bite | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Bronchial Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Gastrointestinal Tract Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Kaposi's Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Laryngeal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Small Intestine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma of the Oral Cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.0 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Intracranial Aneurysm | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Bladder Neck Obstruction | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Renal Disorder | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Variococele | Reproductive system and breast disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Toxic Skin Eruption | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Aortic Intramural Haematoma | Vascular disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Peripheral Artery Aneurysm | Vascular disorders | MedDRA v21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Consitpation | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA v21.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Proteniurea | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Palmar-Plantar Ertythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v21.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stewart Hallett | SFJ Pharmaceuticals | 19252011003 | stewart.hallett@sfj-pharma.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 21, 2017 | Apr 22, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hong Kong |
|
| United States |
|
| Japan |
|
| China |
|
| Taiwan |
|
| France |
|
| India |
|
| Spain |
|
| Overweight + Obese |
|
| Overweight |
|
| Obese |
|
| Underweight |
|
| Missing |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|