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This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration [po] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-NEU Positive | Experimental |
| |
| HER2-NEU Negative | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine [Xeloda] | Drug | 825mg/m2 po bid on days 1-14 of each 3 week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate. | at the time of definitive surgery; after four 3-week cycles (3-4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. | at the time of definitive surgery; after four 3-week cycles (3-4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90057 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | HER2-Neu Negative | Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles |
| FG001 | HER2-Neu Positive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Taxotere |
| Drug |
75mg/m2 iv on day 1 of each 3 week cycle |
|
| Herceptin (HER2-neu positive patients only) | Drug | 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly |
|
| capecitabine [Xeloda] | Drug | 825mg/m2 po bid on days 1-14 of each 3 week cycle |
|
| Taxotere | Drug | 75mg/m2 iv on day 1 of each 3 week cycle |
|
| Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) | The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders. | post 2 and 4, 3-week cycles of treatment |
| Percentage of Participants With Local Recurrence | Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment. | 30 - 1102 days |
| Participants With Disease-Free Survival | Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free. | 30 - 1102 days |
| Participants With Overall Survival | Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment. | 22 - 1191 days |
| Montebello |
| California |
| 90640 |
| United States |
| Palm Springs | California | 92262 | United States |
| San Diego | California | 92123 | United States |
| Farmington | Connecticut | 06030 | United States |
| Melbourne | Florida | 32910 | United States |
| Miami | Florida | 33136 | United States |
| Tamarac | Florida | 33321 | United States |
| Savannah | Georgia | 31405 | United States |
| Indianapolis | Indiana | 46227 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Iowa City | Iowa | 52242 | United States |
| Alexandria | Louisiana | 71301 | United States |
| Scarborough | Maine | 04074 | United States |
| Baltimore | Maryland | 21201 | United States |
| Edina | Minnesota | 55435 | United States |
| Jefferson City | Missouri | 65109 | United States |
| Rolla | Missouri | 65401 | United States |
| St Louis | Missouri | 63141 | United States |
| Neptune City | New Jersey | 07754 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Albuquerque | New Mexico | 87131-5636 | United States |
| Santa Fe | New Mexico | 87505 | United States |
| New York | New York | 10003 | United States |
| Charlotte | North Carolina | 28233-3549 | United States |
| Canton | Ohio | 44718 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pottsville | Pennsylvania | 17901 | United States |
| Charleston | South Carolina | 29425 | United States |
| Georgetown | South Carolina | 29442 | United States |
| Sumter | South Carolina | 29150 | United States |
| Memphis | Tennessee | 38104 | United States |
| Memphis | Tennessee | 38120 | United States |
| Dallas | Texas | 75231 | United States |
| Dallas | Texas | 75390-9034 | United States |
| Burlington | Vermont | 05401 | United States |
| Abingdon | Virginia | 24211 | United States |
Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles |
| Pathological Response |
|
| Clinical Response |
|
| Safety Population |
|
| Quality of Life Population |
|
| Postoperative |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HER2-Neu Negative | Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles |
| BG001 | HER2-Neu Positive | Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles |
| 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 | Safety Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | 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 | Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate. | Pathological Response Evaluable Population | Posted | Number | 95% Confidence Interval | percentage of participants | at the time of definitive surgery; after four 3-week cycles (3-4 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery | Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. | Pathological Response Evaluable Population | Posted | Number | 95% Confidence Interval | percentage of participants | at the time of definitive surgery; after four 3-week cycles (3-4 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR)) | The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders. | Evaluable Population | Posted | Number | 95% Confidence Interval | percentage of participants | post 2 and 4, 3-week cycles of treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Local Recurrence | Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment. | Postoperative Response Evaluable Population | Posted | Number | 95% Confidence Interval | percentage of participants | 30 - 1102 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Participants With Disease-Free Survival | Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free. | The analysis was done on the Postoperative Response Evaluable Population. | Posted | Number | participants | 30 - 1102 days |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With Overall Survival | Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment. | The analysis was done on the post-operative Response Evaluable Population. | Posted | Number | participants | 22 - 1191 days |
|
Cycle 1, Cycle 2, Cycle 3, Cycle 4, at Surgery, and the month 1 visit during the postoperative follow-up period
Intensity of AEs was graded according to the NCI CTCAE version 3.0 on a 5-point scale (grade 1 to 5), clinical laboratory parameters (hematology, chemistry, and urinalysis as clinically indicated), and vital signs.
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 | HER2-Neu Negative | Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 HER2-neu negative: capecitabine + docetaxel Duration: Four 3-week treatment cycles | 15 | 122 | 121 | 122 | ||
| EG001 | HER2-Neu Positive | Dose and route per treatment cycle (Q3W): Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly HER2-neu positive: capecitabine + docetaxel + trastuzumab Duration: Four 3-week treatment cycles | 7 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| 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 |
|---|---|
| D000069287 | Capecitabine |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|