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The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEE011 | Experimental | LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEE011 | Drug | Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments | Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm. FAS | Baseline up ≥16 weeks up to approximately 36 months |
| Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS | CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS | Baseline and ≥ 16 weeks up to approximately 36 months |
| Overall Response Rate (ORR) ≥ 16 Weeks. FAS | ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of the last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progressive disease is defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Alaska Clinical Research |
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There were 176 patients screened
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| ID | Title | Description |
|---|---|---|
| FG000 | Ribociclib 600 mg | LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2015 | Jan 16, 2019 |
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| Baseline and ≥ 16 weeks up to approximately 36 months |
| Every 8 weeks until death, assessed up to 24 months |
| Overall Survival (OS) | Number of participants Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. | Baseline up to approximately 36 months |
| Number of Days for Duration of Response for Responders | Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. | Baseline up to approximately 36 months |
| Anchorage |
| Alaska |
| 99503 |
| United States |
| Arizona Oncology Associates Dept. Of Onc. | Phoenix | Arizona | United States |
| University of Arkansas/ Arkansas Cancer Research Center UA Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PCR Oncology | Pismo Beach | California | 93449 | United States |
| University of California Davis Cancer Center UC Davis Cancer (3) | Sacramento | California | 95817 | United States |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States |
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Yale University School of Medicine Smilow Cancer Hospital | New Haven | Connecticut | 06520 | United States |
| Whittingham Cancer Center Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Stamford Hospital Med. Oncology Hematology Res. | Stamford | Connecticut | 06902 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| NorthWest Georgia Oncology Centers NW Georgia Oncology | Marietta | Georgia | 30060 | United States |
| Harbin Clinic Medical Oncology Clin. Res. | Rome | Georgia | 30165 | United States |
| Queen's Medical Center Queens Cancer Center | Honolulu | Hawaii | 96817 | United States |
| Northwestern Medicine Developmental Therapeutics Institute | Chicago | Illinois | 60611 | United States |
| Indiana University Indiana Univ. - Purdue Univ. | Indianapolis | Indiana | 46202 | United States |
| Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. | South Bend | Indiana | 46617 | United States |
| University of Iowa Hospitals & Clinics Regulatory Contact 2 | Iowa City | Iowa | 52242 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| St. Agnes Hospital St. Agnes Hospital (2) | Baltimore | Maryland | 21229 | United States |
| Michigan Medicine University of Michigan Int. Medicine Oncology | Ann Arbor | Michigan | 48109 5271 | United States |
| Cancer and Hematology Centers of West Michigan Dept. of Oncology | Grand Rapids | Michigan | 49546 | United States |
| Saint Luke's Hospital/Marion Bloch Neuroscience Institute St. Luke's Hospital (4) | Kansas City | Missouri | 64111 | United States |
| Research Medical Center Research Med Center (2) | Kansas City | Missouri | 64132 | United States |
| Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2) | Las Vegas | Nevada | 89109 | United States |
| Cooper Health System Cooper Health System (5) | Camden | New Jersey | 08103 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87106 | United States |
| Cancer Center at Presbyterian | Albuquerque | New Mexico | United States |
| Broome Oncology Broome Oncology (2) | Johnson City | New York | 13790 | United States |
| University of N C at Chapel Hill Physician Office Building | Chapel Hill | North Carolina | 27599-7600 | United States |
| Carolina Oncology Specialists, PC | Hickory | North Carolina | 28602 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Oncology Hematology Care Inc Oncology Hematology Care 2 | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic Foundation Taussig Cancer Institute | Cleveland | Ohio | 44195 | United States |
| Ohio State University Medical Center Comprehensive Cancer Center | Columbus | Ohio | 43221 | United States |
| Oregon Health and Science University Oregon Health & Science U (56) | Portland | Oregon | 97239 | United States |
| Salem Health | Salem | Oregon | 97309 | United States |
| Fox Chase Cancer Center Dept of Medical Oncology | Philadelphia | Pennsylvania | 19111 | United States |
| Rhode Island Hospital Rhode Island Hosp. (2) | Providence | Rhode Island | 02903 | United States |
| Greenville Health System ITOR - Cancer Institute | Greenville | South Carolina | 29615 | United States |
| Sanford University of South Dakota Medical Center Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology | Chattanooga | Tennessee | 37404 | United States |
| The West Clinic Dept. of the West Clinic | Memphis | Tennessee | 38120 | United States |
| Tennessee Oncology Tennessee Oncology (3) | Nashville | Tennessee | 37203 | United States |
| Coastal Bend Cancer Center | Corpus Christi | Texas | 78404 | United States |
| Oncology Consultants Oncology Group | Houston | Texas | 77024 | United States |
| MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3) | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio Cancer Therapy & Research Ctr. | San Antonio | Texas | 78229 | United States |
| Intermountain Medical Center Intermountain Healthcare | Murray | Utah | 84157 | United States |
| Utah Cancer Specialists Utah Cancer Specialists (11) | Salt Lake City | Utah | 84106 | United States |
| Shenandoah Oncology Shenadoah Oncology (2) | Winchester | Virginia | 22601 | United States |
| Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | United States |
| Vista Oncology Inc. PS | Olympia | Washington | 98502 | United States |
| Multicare Research Institute | Tacoma | Washington | 98405 | United States |
| Northwest Medical Specialties Rainier Physicians, PC | Tacoma | Washington | 98405 | United States |
| Providence St. Mary Regional Cancer Center | Walla Walla | Washington | 98057 | United States |
| Wenatchee Valley Medical Center Wenatchee Valley | Wenatchee | Washington | 98801 | United States |
| Aurora Research Institute Aurora Health Care | Milwaukee | Wisconsin | 53226 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Patients With Solid Tumors |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ribociclib 600 mg | LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Primary tumor type | Primary tumor type was sponsor adjudicated. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Number of participants who had radiotherapy, surgery and liver metastasis | Count of Participants | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status for participants | ECOG: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments | Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm. FAS | Posted | Count of Participants | Participants | Baseline up ≥16 weeks up to approximately 36 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS | CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS | Posted | Number | 95% Confidence Interval | participant | Baseline and ≥ 16 weeks up to approximately 36 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of the last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progressive disease is defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression) | Posted | Median | 95% Confidence Interval | months | Every 8 weeks until death, assessed up to 24 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Number of participants Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 36 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days for Duration of Response for Responders | Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. | Posted | Number | Days | Baseline up to approximately 36 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Overall Response Rate (ORR) ≥ 16 Weeks. FAS | ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS | Posted | Number | 95% Confidence Interval | participant | Baseline and ≥ 16 weeks up to approximately 36 months |
|
|
Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) which was an average of 2.7 months up to maximum of 36.2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ribociclib 600 mg | LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days. | 14 | 106 | 40 | 106 | 104 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-888-669-6682 | Novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 10, 2017 | Jan 16, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D008223 | Lymphoma |
| D008654 | Mesothelioma |
| D007938 | Leukemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018301 | Neoplasms, Mesothelial |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589651 | ribociclib |
Not provided
Not provided
Not provided
| Asian |
|
| Other |
|
| Breast-triple negative |
|
| Cervix |
|
| Cholangio |
|
| Chordoma |
|
| Colorectal |
|
| Esophagus |
|
| Gall bladder ducts |
|
| Gastroesophageal junction |
|
| Gastrointestinal stromal tumor |
|
| Head and neck non-squamous cell carcinoma |
|
| Head and neck squamous cell carcinoma |
|
| Kidneys |
|
| Liver |
|
| Lung non-small cell adenocarcinoma |
|
| Lung non-small cell non-adenocarcinoma |
|
| Lung non-small cell squamous |
|
| Lymphoma |
|
| Mesothelioma |
|
| Neuroendocrine |
|
| Ovarian |
|
| Pancreas |
|
| Penile |
|
| Prostate |
|
| Salivary gland |
|
| Sarcoma |
|
| Skin non-melanoma |
|
| Thyroid |
|
| Unknown primary |
|
| Uterus |
|
| Liver metastasis |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Progressive disease (PD) |
|
| Non-evaluable (NE) |
|
|
|
| Title | Denominators | Categories |
|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|