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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006715-22 | EudraCT Number | ||
| CP12-0708 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer
Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated.
Angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. It is the physiological process involving the growth of new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. This may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival.
Ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramucirumab + paclitaxel + carboplatin | Experimental | Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Progression-free (PFS) at 6 Months | Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Participants Reporting Adverse Events | Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. |
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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 |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Beverly Hills | California | 90211 | United States | ||
| ImClone Investigational Site |
52 participants signed informed consent
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab + Paclitaxel + Carboplatin | ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle. paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles. carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight. Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | 200 milligrams per meter squared (mg/m^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles. |
|
| Carboplatin | Drug | Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6. |
|
| Baseline up to 32.5 months |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR]) | Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100. | First dose to measured progressive disease or death due to any cause up to 32.5 months |
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. | First dose up to 32.5 months |
| Overall Survival (OS) at 1 Year | Data presented are the percentage of participants surviving at least 12 months after first dose of study medication. | First dose to 1 year |
| Progression-free Survival (PFS) | Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy. | First dose to measured progressive disease or death due to any cause, up to 32.5 months |
| Overall Survival (OS) | Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive. | First dose to death due to any cause, up to 32.5 months |
| Serum Anti-Ramucirumab Antibody Assessment | The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline. | Week 15 (Cycle 5) |
| Maximum Concentration of Ramucirumab (Cmax) | Week 18 (Cycle 6), at 1-Hour Post End of Infusion |
| San Francisco |
| California |
| 94143 |
| United States |
| ImClone Investigational Site | Aurora | Colorado | 80045 | United States |
| ImClone Investigational Site | New York | New York | 10016 | United States |
| ImClone Investigational Site | The Bronx | New York | 10467 | United States |
| ImClone Investigational Site | San Antonio | Texas | 78229 | United States |
| ImClone Investigational Site | Seattle | Washington | 98104 | United States |
| ImClone Investigational Site | Cambridge | United Kingdom |
| ImClone Investigational Site | London | United Kingdom |
| Received Any Quantity of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent to treat population (mITT): All participants who received any quantity of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab + Paclitaxel + Carboplatin | ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle. paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles. carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight. Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks. |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Percentage of Participants Who Are Progression-free (PFS) at 6 Months | Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Summary of Participants Reporting Adverse Events | Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. | Safety Population: All participants who received any quantity of study drug. | Posted | Number | participants | Baseline up to 32.5 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR]) | Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose to measured progressive disease or death due to any cause up to 32.5 months |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. | Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis. | Posted | Median | 95% Confidence Interval | months | First dose up to 32.5 months |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at 1 Year | Data presented are the percentage of participants surviving at least 12 months after first dose of study medication. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored. | Posted | Median | 95% Confidence Interval | months | First dose to measured progressive disease or death due to any cause, up to 32.5 months |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. Fourteen participants were censored. | Posted | Median | 95% Confidence Interval | months | First dose to death due to any cause, up to 32.5 months |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Anti-Ramucirumab Antibody Assessment | The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline. | Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5). | Posted | Number | participants | Week 15 (Cycle 5) |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Concentration of Ramucirumab (Cmax) | Participants who received any quantity of study medication and had evaluable concentration data at the specified time point. | Posted | Mean | Standard Deviation | micrograms/milliliter (mcg/mL) | Week 18 (Cycle 6), at 1-Hour Post End of Infusion |
|
|
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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 | Ramucirumab + Paclitaxel + Carboplatin | ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle. paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles. carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight. Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks. | 19 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CATHETER SEPSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| PERIANAL ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SYNCOPE VASOVAGAL | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| TEMPERATURE INTOLERANCE | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PELVIC DISCOMFORT | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NASAL DRYNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ORTHOPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| 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 |
|---|---|
| D000096662 | Ramucirumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
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