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| ID | Type | Description | Link |
|---|---|---|---|
| H8Z-MC-JACR | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Docetaxel | Active Comparator | Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy |
|
| B: LY2181308 + Docetaxel | Experimental | LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone | PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug. | Baseline to measured progressive disease or death due to any cause up to 44.68 months |
| Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. | First treatment dose up to 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Profile | Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | Study treatment discontinuation up to 30 days post study treatment discontinuation |
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-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. | Memphis | Tennessee | 38138 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24722180 | Derived | de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. |
| FG001 | LY2181308 + Docetaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| LY2181308 sodium | Drug | LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy. |
|
| Prednisone | Drug | Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy |
|
| First treatment dose up to 19 months |
| Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity) | Predose up to 8 hours postdose in Cycle 1 |
| Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate) | PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated. | Baseline, 18 months |
| Estimate Overall Survival | Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug. | First treatment to death due to any cause up to 45.54 months |
| Estimate Duration of Overall Response | The duration of response [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 or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact. | Time of response to time of measured progressive disease up to 41.00 months |
| Percentage of Participants With Complete Response or Partial Response (Overall Response Rate) | Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Baseline to measured progressive disease up to 41.00 months |
| Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses) | G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline. | Baseline, 21 days |
| Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes) | The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. | 3 months |
| Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms) | The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms. | 3 months |
| 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. | Augsburg | 86150 | Germany |
| 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. | Frankfurt | 60488 | Germany |
| 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. | Hanover | 30625 | Germany |
| 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. | Heidelberg | 69115 | Germany |
| 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. | Heilbronn | D-74078 | Germany |
| 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. | Homburg | 66421 | Germany |
| 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. | Muenchen-Planegg | 82152 | Germany |
| 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. | Gdansk | 80-219 | Poland |
| 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. | Kielce | 25-734 | Poland |
| 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. | Olsztyn | 10-228 | Poland |
| 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. | Warsaw | 02-781 | Poland |
| 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. | Barcelona | 08036 | 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. | Benidorm | 03501 | 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. | Elda | 03600 | 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. | Madrid | 28050 | 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. | Pamplona | 31008 | Spain |
LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy.
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. |
| BG001 | LY2181308 + Docetaxel | LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone | PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug. | All randomized participants who received at least one dose of the study drug. The numbers of participants censored were 10 (Docetaxel group) and 22 (LY2181308 + Docetaxel group). | Posted | Median | 90% Confidence Interval | months | Baseline to measured progressive disease or death due to any cause up to 44.68 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | First treatment dose up to 19 months |
| ||||||||||||||||||||||||||||||
| Secondary | Adverse Event Profile | Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | First treatment dose up to 19 months |
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity) | All randomized participants who received at least one dose of the study drug and had pharmacokinetics data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Predose up to 8 hours postdose in Cycle 1 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate) | PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated. | All randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline, 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Estimate Overall Survival | Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug. | All randomized participants who received at least one dose of study drug. The numbers of participants censored were 25 (Docetaxel group) and 49 (LY2181308 + Docetaxel group). | Posted | Median | 90% Confidence Interval | months | First treatment to death due to any cause up to 45.54 months |
| ||||||||||||||||||||||||||||||
| Secondary | Estimate Duration of Overall Response | The duration of response [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 or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact. | All randomized participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR). The numbers of participants censored were 3 (Docetaxel group) and 1 (LY2181308 + Docetaxel group). | Posted | Median | 90% Confidence Interval | months | Time of response to time of measured progressive disease up to 41.00 months |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response or Partial Response (Overall Response Rate) | Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | All randomized participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to measured progressive disease up to 41.00 months |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses) | G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline. | All randomized participants who received at least one dose of study drug and had G-CSF measurement at baseline and 21 days. | Posted | Number | percentage change | Baseline, 21 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes) | The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. | All randomized participants who received at least one dose of study drug and had FACT-P assessment at 3 months. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
| ||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms) | The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms. | All randomized participants who received at least one dose of study drug and had FACT-G assessment at 3 months. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment | All randomized participants who received at least one dose of the study drug. | Posted | Count of Participants | Participants | No | Study treatment discontinuation up to 30 days post study treatment discontinuation |
|
|
Not provided
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel | Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. | 11 | 51 | 50 | 51 | ||
| EG001 | LY2181308 + Docetaxel | LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. | 47 | 98 | 94 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | 14.1 | Systematic Assessment | Resulted in 1 death in the LY2181308 + Docetaxel group. |
|
| Myocardial infarction | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | 14.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 14.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 14.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 14.1 | Systematic Assessment | Resulted in 1 death in the LY2181308 + Docetaxel group. |
|
| Septic shock | Infections and infestations | 14.1 | Systematic Assessment | Resulted in 1 death in the LY2181308 + Docetaxel group. |
|
| Soft tissue infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 14.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Cranial nerve disorder | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | 14.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 14.1 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 14.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | 14.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 14.1 | Systematic Assessment |
| |
| Chills | General disorders | 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 14.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 14.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 14.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 14.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | 14.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 14.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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|
| African |
|
| Hispanic |
|
| East Asian |
|
| Spain |
|
| Poland |
|
| Germany |
|
| Puerto Rico |
|
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