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This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bexarotene with carboplatin and paclitaxel | Experimental |
| |
| carboplatin and paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bexarotene with carboplatin and paclitaxel | Drug | bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From date of randomization to date of death |
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Patients must have:
Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
Patients must not have had:
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| Name | Affiliation | Role |
|---|---|---|
| Mack Mabry, M.D. | Ligand Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery Cancer Center, L.L.C. | Montgomery | Alabama | 36106 | United States | ||
| Arizona Clinical Research Center, Inc. |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexarotene With Carboplatin and Paclitaxel | bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| carboplatin and paclitaxel | Drug | carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Bay Area Cancer Research Group, LLC | Concord | California | 94520 | United States |
| Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | United States |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley | California | 92708 | United States |
| California Cancer Care, Inc. | Greenbrae | California | 94909 | United States |
| Coast Hematology and Oncology Associates | Long Beach | California | 90806 | United States |
| Metropolitan Hematology/Oncology Medical Group | Los Angeles | California | 90057 | United States |
| Sant P. Chawla, Inc. | Los Angeles | California | 90067 | United States |
| UCLA Medical Center | Los Angeles | California | 94115 | United States |
| Sutter Gould Medical Foundation | Modesto | California | 95355 | United States |
| Medical Oncology Care Associates | Orange | California | 92868 | United States |
| Southern California Kaiser Permanente Medical Group | San Diego | California | 92120 | United States |
| Sharp Health Care | San Diego | California | 92123 | United States |
| UCSF/Mount Zion Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Medical Group of North County, Inc., San Diego Cancer Center | Vista | California | 92083 | United States |
| Rocky Mountain Cancer Centers - Midtown | Denver | Colorado | 80218 | United States |
| Eastern Connecticut Hematology & Oncology | Norwich | Connecticut | 06360 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton | Florida | 33428 | United States |
| University of Florida/Jacksonville | Jacksonville | Florida | 32209 | United States |
| Watson Clinic | Lakeland | Florida | 33805 | United States |
| Oncology and Radiation Associates | Miami | Florida | 33133 | United States |
| Florida Cancer Institute | New Port Richey | Florida | 34652 | United States |
| Florida Oncology Associates | Orange Park | Florida | 32073 | United States |
| Cancer Centers of Florida, P.A. | Orlando | Florida | 32806 | United States |
| South Florida Oncology & Hematology Consultants | Plantation | Florida | 33324 | United States |
| Medical Oncology Associates of Augusta | Augusta | Georgia | 30901 | United States |
| Georgia Oncology Partners Research & Education Foundation | Marietta | Georgia | 30060 | United States |
| St. Luke's/Mountain State Tumor Institute (MSTI) | Boise | Idaho | 83712 | United States |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Northwest Oncology and Hematology, SC | Elk Grove Village | Illinois | 60007 | United States |
| Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068 | United States |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria | Illinois | 61602 | United States |
| Hematology Oncology Assoc. of Illinois | Skokie | Illinois | 60077 | United States |
| Central Indiana Cancer Centers | Indianapolis | Indiana | 46227 | United States |
| Cancer Care Center | New Albany | Indiana | 47150 | United States |
| Michiana Hematology-Oncology | South Bend | Indiana | 46601 | United States |
| Kansas City Oncology and Hematology Group, Kansas City Cancer Centers | Overland Park | Kansas | 66210 | United States |
| Drs. Carroll, Sheth, and Raghavan | Louisville | Kentucky | 40215 | United States |
| Southwest Oncology Associates | Lafayette | Louisiana | 70503 | United States |
| APMC | Metairie | Louisiana | 70006 | United States |
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Chesapeake Oncology-Hematology Associates | Baltimore | Maryland | 21225 | United States |
| Associates in Oncology/Hematology PC | Rockville | Maryland | 20850 | United States |
| Berkshire Hematology Oncology, PC | Pittsfield | Massachusetts | 01201 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Providence Cancer Institute | Southfield | Michigan | 48075 | United States |
| St. Lukes Hospital | Duluth | Minnesota | 55805 | United States |
| Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota | 55407 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| Hematology Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | United States |
| Montana Cancer & Infectious Disease Specialists | Missoula | Montana | 59802 | United States |
| Cancer and Blood Specialists of Nevada | Henderson | Nevada | 89014 | United States |
| Nevada Cancer Center | Las Vegas | Nevada | 89109 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Orange Medical Group | East Orange | New Jersey | 07018 | United States |
| VA New Jersey Health Care System | East Orange | New Jersey | 07018 | United States |
| Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey | 07962 | United States |
| Somerset Hematology Oncology Associates | Somerset | New Jersey | 08873 | United States |
| University of Medicine & Dentistry of NJ, School of Osteopathic Medicine | Stratford | New Jersey | 08084 | United States |
| Overlook Oncology Center | Summit | New Jersey | 07901 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates | Albany | New York | 12208 | United States |
| Erie Medical Center | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Arena Oncology Associates | Great Neck | New York | 11021 | United States |
| Cancer Institute of Long Island, Inc. | Great Neck | New York | 11023 | United States |
| Cancer Research of Long Island, Inc. | Great Neck | New York | 11023 | United States |
| Broome Oncology, LLC | Johnson City | New York | 13790 | United States |
| New York Presbyterian Hospital, Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| VA Medical Center | Northport | New York | 11768 | United States |
| New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates | Rexford | New York | 12148 | United States |
| South Shore Hematology Oncology Associates, PC | Rockville Centre | New York | 11570 | United States |
| Raleigh Hematology Oncology Clinic | Cary | North Carolina | 27511 | United States |
| Northwest Carolina Oncology and Hematology, P.A. | Hickory | North Carolina | 28602 | United States |
| Nashat Y. Gabrail, MD, Inc. | Canton | Ohio | 44718 | United States |
| University of Cincinnati, Barrett Cancer Center | Cincinnati | Ohio | 45219 | United States |
| Columbus Community Clinical Oncology Program | Columbus | Ohio | 43206 | United States |
| Dayton Oncology/Hematology Consultants | Dayton | Ohio | 45439 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cancer Care Associates - Mercy Campus | Oklahoma City | Oklahoma | 73120 | United States |
| Cancer Care Associates | Tulsa | Oklahoma | 74136 | United States |
| Oncology/Hematology, Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| Oncology Hematology of Lehigh Valley, PC | Bethlehem | Pennsylvania | 18015 | United States |
| Medical Oncology Associates of Wyoming Valley, PC | Kingston | Pennsylvania | 18704 | United States |
| Charleston Hematology Oncology P.A. | Charleston | South Carolina | 29403 | United States |
| Liberty Hematology/Oncology | Columbia | South Carolina | 29203 | United States |
| WJB Dorn VA Medical Center | Columbia | South Carolina | 29209 | United States |
| Cancer Centers of the Carolinas | Seneca | South Carolina | 29672 | United States |
| Santee Hematology/Oncology | Sumter | South Carolina | 29150 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Boston Baskin Cancer Group | Memphis | Tennessee | 38104 | United States |
| Texas Oncology, P.A. | Arlington | Texas | 76012 | United States |
| South Austin Cancer Center | Austin | Texas | 78745 | United States |
| Lone Star Oncology Consultants, P.A. | Austin | Texas | 78759 | United States |
| Cancer Specialists of South Texas, PA | Corpus Christi | Texas | 78412 | United States |
| Texas Cancer Center at Medical City | Dallas | Texas | 75230 | United States |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | United States |
| Texas Oncology, P.A. | Fort Worth | Texas | 76104 | United States |
| Texas Oncology, P.A. | Garland | Texas | 75042 | United States |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Allison Cancer Center | Midland | Texas | 79701 | United States |
| West Texas Cancer Center | Odessa | Texas | 79761 | United States |
| Hope Oncology | Richardson | Texas | 75080 | United States |
| Hematology & Oncology Associates of South Texas | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Texoma Cancer Center | Wichita Falls | Texas | 76310 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Arlington Fairfax Hematology Oncology | Arlington | Virginia | 22205 | United States |
| Hematology Oncology Patient Enterprises, Center for Cancer Care | Charlottesville | Virginia | 22902 | United States |
| Danville Hematology & Oncology, Inc. | Danville | Virginia | 24541 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Stark MD, PC | Portsmouth | Virginia | 23707 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc. | Yakima | Washington | 98902 | United States |
| Morgantown Internal Medicine Group | Morgantown | West Virginia | 26505 | United States |
| Sozialmedizinisches Zentrum | Vienna | 1145 | Austria |
| Kaiser-Franz-Josef-Spital | Vienna | A-1100 | Austria |
| Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie | Wels | 4600 | Austria |
| Algoma Regional Cancer Program - Sault Area Hospital | Sault Ste. Marie | Ontario | P6A 2C4 | Canada |
| Humber River Regional Hospital | Weston | Ontario | M9N 1N8 | Canada |
| S.M.B.D. Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier du Pays d'Aix | Aix-en-Provence | 13616 | France |
| Centre Hospitalier General de la Region Annecienne | Annecy | 47011 | France |
| Centre Hospitalier d'Antibes-Juan-Les-Pins | Antibes | 06606 | France |
| CHRU Hopital de Bois Guillaume | Bois-Guillaume | 76230 | France |
| DOP International | Créteil | 94010 | France |
| Hopital de Draguignan | Draguignan | 83300 | France |
| Centre Hospitalier General | Gap | 05007 | France |
| Hopital du Cluzeau | Limoges | 87042 | France |
| CHU Hopital St. Marguerite | Marseille | 29274 | France |
| Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque | Montpellier | 34298 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| CHU - Hopital Nord | Saint-Etienne | 42055 | France |
| Hopital Saint Anne | Toulon Naval | 83800 | France |
| Service de Pneumology, Hopital Adulte de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Centre Hospitalier | Villefranche Sur Soane | 69655 | France |
| Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach | Andernach | D-56626 | Germany |
| Aesklepios-Fachkliniken Muchen-Gauting | Gauting | D-82131 | Germany |
| Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie | GroBhansdorf | 22927 | Germany |
| Ludwig-Maximilians Universitat Munchen | München | 80336 | Germany |
| Charite Universitatsklinikum der Humboldt-Universitat zu Berlin | SchumannstraBe, Berlin | 10117 | Germany |
| Hospital Provincial de Castellon | Castellon | 12002 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46 017 | Spain |
| Hospital Universitario La Fe Servicio de Oncologia | Valencia | 46018 | Spain |
| Hospital Arnau de Villanova, Servicio de Oncologia | Valencia | 46039 | Spain |
| Hospital Clinico Universitario, Servicio Hematologia y Oncologia | Valencia | 46044 | Spain |
| Hospital de Sagunto Servicio de Oncologia | Valencia | 46520 | Spain |
| Carboplatin and Paclitaxel |
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bexarotene With Carboplatin and Paclitaxel | bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. |
| BG001 | Carboplatin and Paclitaxel | carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Counts are correct as reported. The BL measure title of "race" does not include counts of Hispanic or Latino population- which are reported in the BL measure title of "Ethnicity." | 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 | Overall Survival | Intent-to-Treat (ITT) | Posted | Median | Full Range | Months | From date of randomization to date of death |
|
|
|
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Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
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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 | Bexarotene With Carboplatin and Paclitaxel | bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. | 256 | 293 | 293 | 293 | ||
| EG001 | Carboplatin and Paclitaxel | carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. | 242 | 295 | 295 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Non-small cell lung cancer Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Pancytopenia | Blood and lymphatic system disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Pericardial effusion | Cardiac disorders |
| |||
| Pyrexia | General disorders |
| |||
| Asthenia | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Pain | General disorders |
| |||
| Hepatic failure | Hepatobiliary disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Sepsis | Infections and infestations |
| |||
| Convulsion | Nervous system disorders |
| |||
| Cerebrovascular accident | Nervous system disorders |
| |||
| Spinal cord compression | Nervous system disorders |
| |||
| Polyneuropathy | Nervous system disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Hypotriglyceridemia | Metabolism and nutrition disorders |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hypercholesterolemia | Metabolism and nutrition disorders |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hypokalaemia | Metabolism and nutrition disorders |
| |||
| Hyperglycaemia | Metabolism and nutrition disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Hyperlipidemia | Metabolism and nutrition disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Neuropathy peripheral | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Paraesthesia | Nervous system disorders |
| |||
| Polyneuropathy | Nervous system disorders |
| |||
| Neuropathy | Nervous system disorders |
| |||
| Dysgeusia | Nervous system disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Hoarseness | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Flushing | Vascular disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Abdominal pain upper | Gastrointestinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Pruritis | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders |
| |||
| Dry skin | Skin and subcutaneous tissue disorders |
| |||
| Skin desquamation | Skin and subcutaneous tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Fatigue | General disorders |
| |||
| Asthenia | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Pain | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Weight decreased | Investigations |
| |||
| Blood triglycerides increased | Investigations |
| |||
| Hypothyroidism | Endocrine disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai, Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077610 | Bexarotene |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D056831 | Coordination Complexes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|