Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-30605 | |||
| CDR0000573832 | Registry Identifier | NCI Physician Data Query |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.
Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel + carboplatin + radiation + erlotinib | Experimental | Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
| ||
| erlotinib hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 12 Months | Percentage of participants who were alive at 12 months. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Response rate is reported as the percentage of participants who achieved each response. |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:
Must meet the following criteria:
Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Nonmeasurable lesions include the following:
Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist
Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months
Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria
Pleural effusions meeting the following criteria allowed:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rogerio Lilenbaum, MD | Cleveland Clinic Florida | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States | ||
| Valley Medical Oncology Consultants - Castro Valley |
Three participants did not receive any protocol treatment and were excluded from all analyses.
Between March 2008 and October 2011, 78 participants were recruited to this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel + Carboplatin + Radiation + Erlotinib | Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug |
|
| radiation therapy | Radiation |
|
| Duration of study (up to 2 years) |
| Progression-free Survival | Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. | Duration of study (up to 2 years) |
| Castro Valley |
| California |
| 94546 |
| United States |
| Valley Medical Oncology | Fremont | California | 94538 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| Camino Medical Group - Treatment Center | Mountain View | California | 94040 | United States |
| El Camino Hospital Cancer Center | Mountain View | California | 94040 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Breast Surgeons, Incorporated | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Larry G Strieff MD Medical Corporation | Oakland | California | 94609 | United States |
| Tom K Lee, Incorporated | Oakland | California | 94609 | United States |
| Palo Alto Medical Foundation | Palo Alto | California | 94301 | United States |
| Doctors Medical Center - San Pablo Campus | San Pablo | California | 94806 | United States |
| Poudre Valley Radiation Oncology | Fort Collins | Colorado | 80528 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Saint Luke's Hospital - South | Overland Park | Kansas | 66213 | United States |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | United States |
| Harold Alfond Center for Cancer Care | Augusta | Maine | 04330 | United States |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland | 21201 | United States |
| National Naval Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| St. Joseph Medical Center | Kansas City | Missouri | 64114 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | 64118 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | United States |
| Liberty Hospital | Liberty | Missouri | 64068 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | 64507 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Southeastern Regional Medical Center | Lumberton | North Carolina | 28359 | United States |
| Granville Medical Center | Oxford | North Carolina | 27565 | United States |
| Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Duke Health Raleigh Hospital | Raleigh | North Carolina | 27609 | United States |
| Person Memorial Hospital | Roxboro | North Carolina | 27573 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Iredell Memorial Hospital | Statesville | North Carolina | 28677 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | United States |
| Aultman Cancer Center at Aultman Hospital | Canton | Ohio | 44710-1799 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia | 24273 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Three participants did not receive any protocol treatment and were excluded from all analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel + Carboplatin + Radiation + Erlotinib | Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 at 12 Months | Percentage of participants who were alive at 12 months. | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Response Rate | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Response rate is reported as the percentage of participants who achieved each response. | Posted | Number | percentage of participants | Duration of study (up to 2 years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | Duration of study (up to 2 years) |
|
|
Not provided
Not provided
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 | Paclitaxel + Carboplatin + Radiation + Erlotinib | Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy. | 19 | 75 | 71 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac pain | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal mucositis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ileal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Esophageal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Electrocardiogram QTc interval prolonged | Investigations | MedDRA 6 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Mini mental status examination abnormal | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Spleen disorder | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 6 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Flashing vision | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Gait abnormal | General disorders | MedDRA 6 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Visceral edema | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Esophageal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Euphoria | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Kidney pain | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory tract hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Vascular disorder | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rogerio Lilenbaum, M.D. | Yale Cancer Center | Rogerio.lilenbaum@yale.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000069347 | Erlotinib Hydrochloride |
| D013660 | Taxes |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D013812 | Therapeutics |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|