Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-96139 | |||
| NCI-G97-1288 | |||
| CDR0000065672 | Registry Identifier | NCI PDQ |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
OBJECTIVES:
OUTLINE: Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy (stratum 1) and those who have had more than 1 cycle of neoadjuvant chemotherapy and/or modified radical mastectomy (stratum 2).
Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4, 15-19, and 29-32. Paclitaxel is infused over 96 hours on days 43-47 and 57-60. Filgrastim (G-CSF) is administered on days 5-10, 20-25, 33-38, 48-55, and 61-68, and beyond if the granulocyte count is less than 1000/mm^3. A modified radical mastectomy is performed between days 70 and 80. All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104, and cyclophosphamide IV on day 121. Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135. Stem cells are harvested from the patient on days 113-116 and days 132-135.
High-dose chemotherapy is then administered to all patients in the study. Course 1 starts with doxorubicin IV on days -7 to -3. Paclitaxel IV is administered for 24 hours on day -2. Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000/mm^3 for 3 days. Peripheral stem cells are reinfused on day 0. Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11. Filgrastim is administered IV on days -10 to -6. Melphalan and cisplatin are administered again on day -4. Stem cells are infused on day -3 and on day 0. Filgrastim is then administered until the granulocyte count is at least 1000/mm^3 for 3 days.
Radiation therapy is started 4-7 weeks after the beginning of course 2. Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors.
Patients are followed every 3 months for two years and then annually for the next three years.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued, at a rate of about 15 per year.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 cycle of neoadjuvant chemotherapy | Experimental | Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. |
|
| More than 1 cycle of neoadjuvant chemotherapy | Experimental | Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Three-year Relapse-free Survival | Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. | From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy. |
| Five-year Overall Survival | Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause. | From date of mastectomy until date of death, 5 years post mastectomy. |
Not provided
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Stratum 1:
Stratum 2:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| George Somlo, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| cyclophosphamide | Drug |
|
| doxorubicin hydrochloride | Drug |
|
| melphalan | Drug |
|
| mesna | Drug |
|
| paclitaxel | Drug |
|
| tamoxifen citrate | Drug |
|
| bone marrow ablation with stem cell support | Procedure |
|
| conventional surgery | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| FG001 | High-dose Chemo With Rescue | Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation |
| BG001 | High-dose Chemo With Rescue | Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation |
| 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 | Median | Full Range | 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 | Three-year Relapse-free Survival | Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy. |
|
|
| |||||||||||||||||||||||||||||
| Primary | Five-year Overall Survival | Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of mastectomy until date of death, 5 years post mastectomy. |
|
Adverse events were assessed during all cycles of chemotherapy treatment (up to 6 months).
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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 | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin cyclophosphamide doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support conventional surgery peripheral blood stem cell transplantation | 10 | 14 | 0 | 14 | 13 | 14 |
| EG001 | High-dose Chemo With Rescue | Following surgery patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment. filgrastim cisplatin doxorubicin hydrochloride melphalan mesna paclitaxel tamoxifen citrate bone marrow ablation with stem cell support peripheral blood stem cell transplantation | 14 | 27 | 2 | 27 | 23 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Dysrhythmias | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Fluid Retention | Renal and urinary disorders | COH | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | COH | Non-systematic Assessment |
| |
| Ischemia | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Pericardial | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | COH | Non-systematic Assessment |
| |
| Stomatitis | General disorders | COH | Non-systematic Assessment |
| |
| Weight (Food Intake) | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Clinical Coagulation | Blood and lymphatic system disorders | COH | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| EF/CHF | Cardiac disorders | COH | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hearing | Ear and labyrinth disorders | COH | Non-systematic Assessment |
| |
| Hearing loss | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision | Eye disorders | COH | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COH | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Diarrhea (Somlo COH) | Gastrointestinal disorders | Somlo | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (Somlo COH) | Gastrointestinal disorders | Somlo | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Incontinence NOS | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Nausea (Somlo COH) | Gastrointestinal disorders | Somlo | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Stomatitis/phayngitis (Somlo COH) | Gastrointestinal disorders | Somlo | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vomiting (Somlo COH) | Gastrointestinal disorders | Somlo | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Fever (no infection) | General disorders | COH | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Oedema NOS | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | COH | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Infection, Bacterial (COH) | Infections and infestations | COH | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| AGC | Investigations | COH | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Alk Phos (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Investigations | COH | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Amylase | Investigations | COH | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Bilirubin | Investigations | COH | Non-systematic Assessment |
| |
| Bilirubin (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Creatinine | Investigations | COH | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| HGB/HCT | Investigations | COH | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| INR increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophils (ANC) (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Investigations | meddra9.0 | Non-systematic Assessment |
| ||
| Partial Thromboplastin Time | Investigations | COH | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Platelets | Investigations | COH | Non-systematic Assessment |
| |
| Platelets (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| Prothrombin Time | Investigations | COH | Non-systematic Assessment |
| |
| SGOT (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| SGOT/SGT | Investigations | COH | Non-systematic Assessment |
| |
| SGPT (Somlo COH) | Investigations | Somlo | Non-systematic Assessment |
| |
| WBC | Investigations | COH | Non-systematic Assessment |
| |
| Weight gain | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | COH | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cortical/State of Consciousness | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Motor Activity | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral Nervous System Sensory | Nervous system disorders | COH | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hallucination NOS | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ideation | Psychiatric disorders | COH | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mood | Psychiatric disorders | COH | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Blood urine present | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | COH | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | COH | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Extensive Skin Rash | Skin and subcutaneous tissue disorders | COH | Non-systematic Assessment |
| |
| Local Skin Rash | Skin and subcutaneous tissue disorders | COH | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | COH | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Mar 12, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory 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 |
|---|---|
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D008558 | Melphalan |
| D015080 | Mesna |
| D017239 | Paclitaxel |
| D013629 | Tamoxifen |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Male |
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| Hispanic |
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| Black |
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