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| ID | Type | Description | Link |
|---|---|---|---|
| I1Y-MC-JFBD | Other Identifier | Eli Lilly and Company |
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Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A LY2523355 | Experimental | 8 milligrams per square meter (mg/m²) per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity. |
|
| Part B LY2523355 | Experimental | 5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2523355 | Drug | Administered intravenously as a 1-hour infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100. | Date of enrollment to date of measured progressive disease up to 99.6 weeks |
| Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Progression-Free Survival | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. |
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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 9AM-5PM Eastern time(UTC/GMT-5hours, 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. | Torrington | Connecticut | 06790 |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
This is a nonrandomized, open-label, 2-part study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - 8 mg/m²/Day | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| FG001 | Part B - 5 mg/m²/Day | 5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| FG002 | Part B - 6 mg/m²/Day | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A - 8 mg/m²/Day | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| BG001 | Part B - 5 mg/m²/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100. | All participants who received at least 1 dose of study drug in Part A. | Posted | Number | 90% Confidence Interval | percentage of participants | Date of enrollment to date of measured progressive disease up to 99.6 weeks |
|
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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 | Part A - 8 mg/m²/Day | 8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591843 | litronesib |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Granulocyte colony-stimulating factor (G-CSF) | Drug | Administered subcutaneously |
|
| Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks |
| Part B: Progression-Free Survival | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. | Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks |
| Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. | Date of enrollment to date of measured progressive disease 99.6 weeks |
| Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100. | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
| Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
| Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 | Day 3 of Cycle 1 (21-day cycle) |
| Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated. | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
| Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Day 3 of Cycle 1 (21-day cycle) |
| Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI) | LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome). | Baseline and follow-up up to 104 weeks after the first dose of study drug |
| United States |
| 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. | Athens | Georgia | 30607 | United States |
| 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. | Marietta | Georgia | 30060 | United States |
| 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. | Scarborough | Maine | 04074 | United States |
| 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. | Cherry Hill | New Jersey | 08003 | United States |
| 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. | Albuquerque | New Mexico | 87131 | United States |
| 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. | Charleston | South Carolina | 29425 | United States |
| 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. | Memphis | Tennessee | 38138 | United States |
| 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. | Bucharest | 022328 | Romania |
| 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. | Cluj-Napoca | 3400 | Romania |
| 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. | Seoul | 135-710 | South Korea |
5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. |
| BG002 | Part B - 6 mg/m²/Day | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. | All participants who received at least 1 dose of study drug in Part B. | Posted | Number | 90% Confidence Interval | percentage of participants | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
|
|
|
| Secondary | Part A: Progression-Free Survival | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. | All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4. | Posted | Median | 90% Confidence Interval | weeks | Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks |
|
|
|
| Secondary | Part B: Progression-Free Survival | Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment. | All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4. | Posted | Median | 90% Confidence Interval | weeks | Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks |
|
|
|
| Secondary | Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. | All participants who received at least 1 dose of study drug in Part A. | Posted | Number | 90% Confidence Interval | percentage of participants | Date of enrollment to date of measured progressive disease 99.6 weeks |
|
|
|
| Secondary | Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100. | All participants who received at least 1 dose of study drug in Part B. | Posted | Number | 90% Confidence Interval | percentage of participants | Date of enrollment to date of measured progressive disease up to 18.1 weeks |
|
|
|
| Secondary | Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
|
|
|
| Secondary | Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 3 of Cycle 1 (21-day cycle) |
|
|
|
| Secondary | Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated. | No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1. | Posted | Days 1,5 and 9 of Cycle 1 (21-day cycle) |
|
|
| Secondary | Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Day 3 of Cycle 1 (21-day cycle) |
|
|
|
| Secondary | Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI) | LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome). | All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B. | Posted | Mean | Standard Deviation | units on a scale | Baseline and follow-up up to 104 weeks after the first dose of study drug |
|
|
|
| 8 |
| 38 |
| 35 |
| 38 |
| EG001 | Part B - 5 mg/m²/Day | 5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle. | 8 | 18 | 18 | 18 |
| EG002 | Part B - 6 mg/m²/Day | 6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle. | 8 | 8 | 7 | 8 |
| Neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | 15.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 15.1 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 15.1 | Systematic Assessment | Event resulted in a death in Part A |
|
| Sepsis | Infections and infestations | 15.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment | Event resulted in a death in Part A |
|
| Decreased appetite | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 15.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | 15.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 15.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | 15.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Stevens-johnson syndrome | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | 15.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | 15.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | 15.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | 15.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | 15.1 | Systematic Assessment |
|
| Chest pain | General disorders | 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | 15.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | 15.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 15.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 15.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | 15.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | 15.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 15.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 15.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 15.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | 15.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 15.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | 15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | 15.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | 15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | 15.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | 15.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 15.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 15.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | 15.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | 15.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | 15.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | 15.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | 15.1 | Systematic Assessment |
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| Micturition disorder | Renal and urinary disorders | 15.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Sunburn | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 15.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | 15.1 | Systematic Assessment |
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| Superior vena cava syndrome | Vascular disorders | 15.1 | Systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
|
| LY2523355 Day 9 |
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| Metabolite Day 1 |
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| Metabolite Day 5 |
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| Metabolite Day 9 |
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| ASBI at Baseline |
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| ASBI at Follow-up |
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