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| Name | Class |
|---|---|
| Kentucky Lung Cancer Research Program | OTHER |
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The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.
This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy.
Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 No Dex | Other | No Dexamethasone |
|
| 2 Dex | Experimental | Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reduction in Grade 3/4 Neutropenia | Reduction grade 3/4 neutropenia | continuous throughout treatment, up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Dexamethasone Pre-treatment on Response Rate. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rinehart | Lucille P. Markey Cancer Center at University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Commonwealth Cancer Center | Danville | Kentucky | 40422 | United States | ||
| Markey Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23475103 | Result | Rinehart J, Arnold S, Kloecker G, Lim A, Zaydan MA, Baeker T, Maheshwari JG, Carloss H, Slone S, Shelton B, Croley J, Kvale E, Brooks M, Leggas M. Phase II randomized trial of carboplatin and gemcitabine with or without dexamethasone pre-treatment in patients with Stage IV non-small cell lung cancer. Cancer Chemother Pharmacol. 2013 May;71(5):1375-83. doi: 10.1007/s00280-013-2111-3. Epub 2013 Mar 9. |
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Total number of patients enrolled is 60. However, 1 patient enrolled to trial was discontinued from trial prior to receipt of any study therapies; patient was randomized to arm 1 (control, no dexamethasone pretreatment) but received no study therapies or procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Control, no Dexamethasone Pretreatment | Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment. |
| FG001 | Arm 2, Dexamethasone Pretreatment Test Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexamethasone | Drug | 16 mg bid for 4 days prior to each chemotherapy start. |
|
| Carboplatin | Drug | AUC 6.0 intravenously over 30 minutes on day 5. |
|
| Effect of Dexamethasone Pre-treatment on Overall Survival. | Overall survival | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days |
| Progression-free Survival | progression-free survival | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| St. Claire Regional Medical Center | Morehead | Kentucky | 40351 | United States |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | United States |
| Owensboro Medical HealthCare System | Owensboro | Kentucky | 42303 | United States |
| West Kentucky Hematology & Oncology Group, PSC | Paducah | Kentucky | 42003 | United States |
Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1, Control, no Dexamethasone Pretreatment | Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment. |
| BG001 | Arm 2, Dexamethasone Pretreatment Test Arm | Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8). |
| 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 |
| ||||||||||||||||||
| Sex: Female, Male | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Effect of Dexamethasone Pre-treatment on Response Rate. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | 95% Confidence Interval | percentage of responders out of total | Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment |
|
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| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Reduction in Grade 3/4 Neutropenia | Reduction grade 3/4 neutropenia | Posted | Number | percentage of participants | continuous throughout treatment, up to 25 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Effect of Dexamethasone Pre-treatment on Overall Survival. | Overall survival | Posted | Median | 95% Confidence Interval | days | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | progression-free survival | Posted | Median | 95% Confidence Interval | days | Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days |
|
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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 | 1 No Dexamethasone | Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment. | 7 | 26 | 26 | 26 | ||
| EG001 | 2 Dexamethasone | Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8). | 12 | 33 | 33 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | COSTART |
| ||
| LEUKOPENIA | Blood and lymphatic system disorders | COSTART |
| ||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | COSTART |
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| HEART ARREST | Cardiac disorders | COSTART |
| ||
| CONSTIPATION | Gastrointestinal disorders | COSTART |
| ||
| DIARRHEA | Gastrointestinal disorders | COSTART |
| ||
| DUODENAL ULCER | Gastrointestinal disorders | COSTART |
| ||
| NAUSEA | Gastrointestinal disorders | COSTART |
| ||
| RECTAL DISORDER | Gastrointestinal disorders | COSTART |
| ||
| VOMITING | Gastrointestinal disorders | COSTART |
| ||
| MEDICATION ERROR | General disorders | COSTART |
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| SEPSIS | General disorders | COSTART |
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| HYPERGLYCEMIA | Metabolism and nutrition disorders | COSTART |
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| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | COSTART |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | COSTART |
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| DIZZINESS | Nervous system disorders | COSTART |
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| URINARY TRACT INFECTION | Renal and urinary disorders | COSTART |
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| APNEA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| COUGH INCREASED | Respiratory, thoracic and mediastinal disorders | COSTART |
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| DYSPNEA | Respiratory, thoracic and mediastinal disorders | COSTART |
| ||
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| PULMONARY EMBOLUS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| DEEP THROMBOPHLEBITIS | Vascular disorders | COSTART |
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| HYPOTENSION | Vascular disorders | COSTART |
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| MESENTERIC VENOUS OCCLUSION | Vascular disorders | COSTART |
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| THROMBOSIS | Vascular disorders | COSTART |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | COSTART |
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| ECCHYMOSIS | Blood and lymphatic system disorders | COSTART |
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| HYPOCHROMIC ANEMIA | Blood and lymphatic system disorders | COSTART |
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| LEUKOCYTOSIS | Blood and lymphatic system disorders | COSTART |
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| LEUKOPENIA | Blood and lymphatic system disorders | COSTART |
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| PANCYTOPENIA | Blood and lymphatic system disorders | COSTART |
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| PETECHIA | Blood and lymphatic system disorders | COSTART |
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| THROMBOCYTHEMIA | Blood and lymphatic system disorders | COSTART |
| ||
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | COSTART |
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| TACHYCARDIA | Cardiac disorders | COSTART |
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| CUSHINGS SYNDROME | Endocrine disorders | COSTART |
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| CONJUNCTIVITIS | Eye disorders | COSTART |
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| ANOREXIA | Gastrointestinal disorders | COSTART |
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| CHOLECYSTITIS | Gastrointestinal disorders | COSTART |
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| CONSTIPATION | Gastrointestinal disorders | COSTART |
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| DIARRHEA | Gastrointestinal disorders | COSTART |
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| DYSPEPSIA | Gastrointestinal disorders | COSTART |
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| DYSPHAGIA | Gastrointestinal disorders | COSTART |
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| FLATULENCE | Gastrointestinal disorders | COSTART |
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| MOUTH ULCERATION | Gastrointestinal disorders | COSTART |
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| NAUSEA | Gastrointestinal disorders | COSTART |
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| ORAL MONILIASIS | Gastrointestinal disorders | COSTART |
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| RECTAL DISORDER | Gastrointestinal disorders | COSTART |
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| STOMATITIS | Gastrointestinal disorders | COSTART |
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| ULCERATIVE STOMATITIS | Gastrointestinal disorders | COSTART |
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| VOMITING | Gastrointestinal disorders | COSTART |
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| ABDOMINAL PAIN | General disorders | COSTART |
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| ACCIDENTAL INJURY | General disorders | COSTART |
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| ASTHENIA | General disorders | COSTART |
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| BACK PAIN | General disorders | COSTART |
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| CHEST PAIN | General disorders | COSTART |
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| FACE EDEMA | General disorders | COSTART |
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| FEVER | General disorders | COSTART |
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| HEADACHE | General disorders | COSTART |
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| INJECTION SITE PAIN | General disorders | COSTART |
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| INJECTION SITE REACTION | General disorders | COSTART |
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| LAB TEST ABNORMAL | General disorders | COSTART |
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| MUCOUS MEMBRANE DISORDER | General disorders | COSTART |
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| PAIN | General disorders | COSTART |
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| INFECTION FUNGAL | Infections and infestations | COSTART |
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| ALKALINE PHOSPHATASE INCREASED | Metabolism and nutrition disorders | COSTART |
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| BUN INCREASED | Metabolism and nutrition disorders | COSTART |
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| CREATININE INCREASED | Metabolism and nutrition disorders | COSTART |
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| DEHYDRATION | Metabolism and nutrition disorders | COSTART |
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| EDEMA | Metabolism and nutrition disorders | COSTART |
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| GOUT | Metabolism and nutrition disorders | COSTART |
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| HYPERCALCEMIA | Metabolism and nutrition disorders | COSTART |
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| HYPERGLYCEMIA | Metabolism and nutrition disorders | COSTART |
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| HYPOCALCEMIA | Metabolism and nutrition disorders | COSTART |
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| HYPOKALEMIA | Metabolism and nutrition disorders | COSTART |
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| HYPONATREMIA | Metabolism and nutrition disorders | COSTART |
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| HYPOPROTEINEMIA | Metabolism and nutrition disorders | COSTART |
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| PERIPHERAL EDEMA | Metabolism and nutrition disorders | COSTART |
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| RESPIRATORY ALKALOSIS | Metabolism and nutrition disorders | COSTART |
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| SGOT INCREASED | Metabolism and nutrition disorders | COSTART |
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| SGPT INCREASED | Metabolism and nutrition disorders | COSTART |
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| WEIGHT LOSS | Metabolism and nutrition disorders | COSTART |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | COSTART |
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| MYASTHENIA | Musculoskeletal and connective tissue disorders | COSTART |
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| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | COSTART |
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| ANXIETY | Nervous system disorders | COSTART |
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| CONFUSION | Nervous system disorders | COSTART |
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| DEPRESSION | Nervous system disorders | COSTART |
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| DIZZINESS | Nervous system disorders | COSTART |
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| HYPERTENSION | Nervous system disorders | COSTART |
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| INSOMNIA | Nervous system disorders | COSTART |
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| NEUROPATHY | Nervous system disorders | COSTART |
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| PARESTHESIA | Nervous system disorders | COSTART |
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| URINARY RETENTION | Nervous system disorders | COSTART |
| ||
| VASODILATATION | Nervous system disorders | COSTART |
| ||
| KIDNEY FUNCTION ABNORMAL | Renal and urinary disorders | COSTART |
| ||
| URINARY TRACT INFECTION | Renal and urinary disorders | COSTART |
| ||
| COUGH INCREASED | Respiratory, thoracic and mediastinal disorders | COSTART |
| ||
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| HICCUP | Respiratory, thoracic and mediastinal disorders | COSTART |
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| HYPOVENTILATION | Respiratory, thoracic and mediastinal disorders | COSTART |
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| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | COSTART |
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| LUNG EDEMA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | COSTART |
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| RHINITIS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| SINUSITIS | Respiratory, thoracic and mediastinal disorders | COSTART |
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| ALOPECIA | Skin and subcutaneous tissue disorders | COSTART |
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| RASH | Skin and subcutaneous tissue disorders | COSTART |
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| SWEATING | Skin and subcutaneous tissue disorders | COSTART |
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| HYPOTENSION | Vascular disorders | COSTART |
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| PALLOR | Vascular disorders | COSTART |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzane Arnold, MD | University of Kentucky Markey Cancer Center | 859 323 8043 | smarno0@uky.edu |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D003907 | Dexamethasone |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| >=65 years |
|
| Male |
|
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