Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TAX.ES1.301 | Other Identifier | RHÔNE-POULENC RORER, S.A. (RPR) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:
Primary objective:
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: FAC | Active Comparator | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
|
| Arm B: TAC | Experimental | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug |
|
| |
| 5-fluorouracil |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) Events | DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was determined from the date of randomization until the date of death for any reason. OS is calculated from the date of randomization up to the first date of death by any cause. | 10 years |
| The Number of Participants Who Experienced Adverse Events (AE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Hospital Universitario San Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish Breast Cancer Research Group | San Sebastián de los Reyes | Madrid | 28700 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15930421 | Background | Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681. | |
| 21121833 |
| Label | URL |
|---|---|
| home page of the Spanish Breast Cancer Research Group | View source |
Not provided
Not provided
For the different subsets ("Hormone-receptor Positive and HER2 PositiveStatus Subjects", "Hormonal Receptor Positive and HER2 Negative Subjects", etc.), were assessed by central determination, and no all patients had tumor sample available.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: FAC | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide |
| FG001 | Arm B: TAC | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: FAC | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide |
| BG001 | Arm B: TAC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Disease-free Survival (DFS) Events | DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death. | Posted | Number | events | 10 years |
|
Deaths were assessed for up to 10 years. Adverse Events were assessed for an average of 4 months
The safety analysis were conducted on all patients who started at least one infusion of the study 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 | Arm A: FAC | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Director / Medical Lead / Project Manager | Spanish Breast Cancer Research Group | +34916592870 | geicam@geicam.org |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Doxorubicin | Drug |
|
|
| Cyclophosphamide | Drug |
|
|
Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0. |
| Through study treatment, and average of 4 months |
| Best Score During Study for Global Health Status Scale | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used. Questionnaires were self-administered to patients during the 14 days prior to randomisation baseline, at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study. The Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL. | 120 weeks |
| Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | 10 year |
| Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | 10 year |
| Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. | 10 year |
| Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | 10 year |
| Result |
| Martin M, Segui MA, Anton A, Ruiz A, Ramos M, Adrover E, Aranda I, Rodriguez-Lescure A, Grosse R, Calvo L, Barnadas A, Isla D, Martinez del Prado P, Ruiz Borrego M, Zaluski J, Arcusa A, Munoz M, Lopez Vega JM, Mel JR, Munarriz B, Llorca C, Jara C, Alba E, Florian J, Li J, Lopez Garcia-Asenjo JA, Saez A, Rios MJ, Almenar S, Peiro G, Lluch A; GEICAM 9805 Investigators. Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med. 2010 Dec 2;363(23):2200-10. doi: 10.1056/NEJMoa0910320. |
TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor size | Count of Participants | Participants |
|
| Tumor grade | Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells. G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue. G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3. G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster. | Count of Participants | Participants |
|
| Menopausal status | Count of Participants | Participants |
|
| Hormone-receptor status | Count of Participants | Participants |
|
| Surgery | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival (OS) | OS was determined from the date of randomization until the date of death for any reason. OS is calculated from the date of randomization up to the first date of death by any cause. | Posted | Number | Participants with mortality event | 10 years |
|
|
|
| Secondary | The Number of Participants Who Experienced Adverse Events (AE) | Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0. | The safety analysis was conducted on all patients who started at least one infusion of the study treatment (Arm A 519, and Arm B 532). | Posted | Number | participants | Through study treatment, and average of 4 months |
|
|
|
| Secondary | Best Score During Study for Global Health Status Scale | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used. Questionnaires were self-administered to patients during the 14 days prior to randomisation baseline, at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study. The Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL. | Posted | Mean | Standard Deviation | score on a scale | 120 weeks |
|
|
|
| Secondary | Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | Posted | Number | events | 10 year |
|
|
|
| Secondary | Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | Posted | Number | events | 10 year |
|
|
|
| Secondary | Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. | Posted | Number | events | 10 year |
|
|
|
| Secondary | Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. | Posted | Number | events | 10 year |
|
|
|
| 57 |
| 519 |
| 21 |
| 519 |
| 519 |
| 519 |
| EG001 | Arm B: TAC | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide | 53 | 532 | 119 | 532 | 532 | 532 |
| Anaemia | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Asthenia | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Blood bilirubin | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Breast infection | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Breast haematoma | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Carotid artery thrombosis | Cardiac disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC version 1.0 | Systematic Assessment |
|
| Erysipelas | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Febrile neutropenia | Investigations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Fever in absence of infection | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Hypersensitivity | Nervous system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Oedema peripheral | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pyrexia | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pancreatitis | Metabolism and nutrition disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Asthenia | General disorders | NCI-CTC v. 1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pain | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Oedema peripheral | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pyrexia | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Decreased appetite | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Hot flush | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Weight increased | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Bone pain | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Back pain | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Photophobia | Nervous system disorders | NCI-CTC v. 1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Fatigue | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Hyperhidrosis | General disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Infection | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Visual impairment | Nervous system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Anal abscess | Gastrointestinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | NCI-CTC version 1.0 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| One serious treatment-emergent AE |
|
| One serious G3-4 treatment-emergent AE |
|
| Number of patients discontinued due to AE |
|
| Number patients death due to AE |
|