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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-AA-S355 | Other Identifier | Eli Lilly and Company |
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The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Paclitaxel | Experimental | gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. |
|
| Gemcitabine + Carboplatin | Experimental | gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles. |
|
| Gemcitabine + Cisplatin | Experimental | gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Time to Treatment Failure (TTTF) Event | TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation. |
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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 Monday-Friday 9:00 AM to 5:00 PM Est Time (UTC/GMT - 5 hours) | 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. | Santo André | 09060-020 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Paclitaxel | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles |
| FG001 | Gemcitabine + Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| paclitaxel | Drug | 150 mg/m2, IV, every 14 days x 8 cycles |
|
| carboplatin | Drug | Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles |
|
| cisplatin | Drug | 50 mg/m2, IV, every 14 days x 8 cycles |
|
| randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months) |
| Progression Free Survival (PFS) | PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment. | baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization) |
| Duration of Response | Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression. | time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization) |
| Overall Survival | Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up. | baseline to date of death from any cause (up to 34 months) |
| Brazil |
| 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. | São Paulo | 05403-900 | Brazil |
| 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. | Beijing | 100071 | China |
| 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. | Hangzhou | 310016 | China |
| 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. | Nanjing | 210009 | China |
| 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. | Wuhan | 430030 | China |
| 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. | Delhi | 110085 | India |
| 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. | Kolkata | 700053 | India |
| 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. | Ludhiana | 141001 | India |
| 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. | Mumbai | 400016 | India |
| 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. | Pune | 411001 | India |
| 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. | Cuernavaca | 62200 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | 01120 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Villahermosa | 86090 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | 138-736 | South Korea |
| 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. | Antalya | Turkey (Türkiye) |
| 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. | Gaziantep | Turkey (Türkiye) |
| 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. | Kayseri | 38039 | Turkey (Türkiye) |
Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
| FG002 | Gemcitabine + Cisplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Paclitaxel | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles |
| BG001 | Gemcitabine + Carboplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles |
| BG002 | Gemcitabine + Cisplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Menopausal Status | Number | participants |
| ||||||||||||||||
| Pathological Diagnosis | Number | participants |
| ||||||||||||||||
| Race/Ethnicity | 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 | Best Overall Response | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | Number of all randomized participants. | Posted | Number | participants | baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Time to Treatment Failure (TTTF) Event | TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation. | Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 34; Gemcitabine + Carboplatin = 26; Gemcitabine + Cisplatin = 30. | Posted | Oct 2010 | Number | participants | randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment. | Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 20; Gemcitabine + Carboplatin = 18; Gemcitabine + Cisplatin = 28. | Posted | Oct 2010 | Median | 95% Confidence Interval | months | baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression. | Randomized patients who had either a complete response or partial response. Censored patients: Gemcitabine + Paclitaxel = 4; Gemcitabine + Carboplatin = 4; Gemcitabine + Cisplatin = 14. | Posted | Oct 2010 | Median | 95% Confidence Interval | months | time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up. | Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 23; Gemcitabine + Carboplatin = 24; Gemcitabine + Cisplatin = 22. | Posted | Oct 2010 | Median | Full Range | months | baseline to date of death from any cause (up to 34 months) |
|
Not provided
Safety analyses were performed on all enrolled patients who received at least one dose of study therapy. All enrolled patients, except for one patient in Gemcitabine + Cisplatin Arm, received at least one dose of study therapy and qualified for safety analyses. The one patient was a screen failure and was discontinued before receiving study drug.
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 | Gemcitabine + Paclitaxel | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles | 5 | 49 | 48 | 49 | ||
| EG001 | Gemcitabine + Carboplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles | 3 | 47 | 46 | 47 | ||
| EG002 | Gemcitabine + Cisplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles | 0 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA: 9.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA: 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA: 12.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA: 9.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA: 11.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA: 9.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA: 10.0 | 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 |
| |
| Hypotension | Vascular 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 |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Lymphopenia | 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 |
| |
| Palpitations | Cardiac disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA: 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA: 10.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA: 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA: 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA: 9.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA: 9.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA: 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA: 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA: 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA: 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Brazil |
|
| Turkey |
|
| China |
|
| Korea, Republic of |
|
| India |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| Missing Data |
|
| Peri Menopausal |
|
| Post Menopausal |
|
| Missing Data |
|
| Carcinoma, Infiltrating Ductal |
|
| Carcinoma, Infiltrating Lobular |
|
| Carcinoma, Undifferentiated |
|
| Comedocarcinoma |
|
| Missing Data |
|
| Caucasian |
|
| East Asian |
|
| Hispanic |
|
| West Asian (West Indian) |
|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Early Death from Other Causes |
|
| Unknown |
|
| OG002 | Gemcitabine + Cisplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles |
|
|
Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles
|
|
| OG002 | Gemcitabine + Cisplatin | Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|