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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-CR-S111 | Other Identifier | Eli Lilly and Company |
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Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Vitamin and Steroid Schedule + Pemetrexed | Active Comparator | Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. |
|
| Simplified Vitamin and Steroid Schedule + Pemetrexed | Experimental | Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity | Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section. | From first dose of treatment to last dose of treatment plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Best Overall Tumor Response (Response Rate) | Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bankstown | New South Wales | 2200 |
Completed is defined as:The patient has completed follow-up visits until 12 months after the randomization date.
Qualified Intent-to-Treat (Q-ITT) is defined as: Include all randomized patients, with nonsquamous histology, who comply with their pretreatment folic acid and steroid supplementation schedule and take at least one dose of pemetrexed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Vitamin and Steroid Schedule + Pemetrexed | Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. |
| FG001 | Simplified Vitamin and Steroid Schedule + Pemetrexed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Folic acid | Dietary Supplement | 350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed. |
|
|
| Folic Acid | Dietary Supplement | 350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed. |
|
|
| Vitamin B12 | Dietary Supplement | 1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed. |
|
| dexamethasone | Drug | 4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed. |
|
| dexamethasone | Drug | 4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed. |
|
| Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment. |
| Overall Survival | Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact. | Randomization (≤4 weeks from baseline visit) to 12 months after randomization |
| Progression-free Survival (PFS) | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment. | Randomization (≤4 weeks from baseline visit) to 12 months after randomization |
| Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Concord | New South Wales | 2139 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kingswood Penrith | New South Wales | 2747 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liverpool | New South Wales | 2170 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Redcliffe | Queensland | 4020 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bologna | 40100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milan | 20132 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Naples | 80100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pisa | 56100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rome | 00149 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | 14000 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toluca | CP50180 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pozuelo de Alarcón | 28223 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seville | 41014 | Spain |
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only. |
| Completed 6 Treatment Cycles |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Vitamin and Steroid Schedule + Pemetrexed | Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. |
| BG001 | Simplified Vitamin and Steroid Schedule + Pemetrexed | Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only. |
| 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 Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Smoking Status | Number | Participants |
| ||||||||||||||||
| Pathological Diagnosis | Number | Participants |
| ||||||||||||||||
| Disease Stage | Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Differentiation between stage IIIA and IIIB is in accordance with the American Joint Committee on Cancer Staging Criteria for Lung Cancer. | Number | Participants |
| |||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared (kilograms/square meters [kg/m^2]). | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity | Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section. | Qualified Intention to Treat (Q-ITT) | Posted | Number | participants | From first dose of treatment to last dose of treatment plus 30 days |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Best Overall Tumor Response (Response Rate) | Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response. | Qualified Intent to Treat (Q-ITT) | Posted | Mean | 95% Confidence Interval | proportion of patients | Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact. | Qualified Intent to Treat (Q-ITT) | Posted | Median | 95% Confidence Interval | months | Randomization (≤4 weeks from baseline visit) to 12 months after randomization |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment. | Qualified Intent to Treat (Q-ITT) | Posted | Median | 95% Confidence Interval | months | Randomization (≤4 weeks from baseline visit) to 12 months after randomization |
|
|
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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 | Standard Vitamin and Steroid Schedule + Pemetrexed | Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. | 18 | 54 | 47 | 54 | ||
| EG001 | Simplified Vitamin and Steroid Schedule + Pemetrexed | Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only. | 18 | 57 | 54 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| D000068437 | Pemetrexed |
| D005492 | Folic Acid |
| D014805 | Vitamin B 12 |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D011622 | Pterins |
| D011621 | Pteridines |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Mexico |
|
| Italy |
|
| Australia |
|
| 1- Ambulatory, Restricted Strenuous Activity |
|
| 2- Ambulatory, No Work Activities |
|
| Not Assessed |
|
| Never Smoked |
|
| Current Smoker |
|
| Histopathological |
|
| IIIB |
|
| IV |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|