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This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| 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 |
|---|---|---|
| Disease Free Survival [Number of Events] | Number of patients with/without recurrence of breast cancer, or death due to any cause. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Disease Free Survival [Time to Event] | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival [Number of Events] | Number of patients who died/were alive. | Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
| Overall Survival [Time to Event] |
Not provided
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 |
|---|---|---|---|---|---|---|
| Houston | Texas | 77060 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037241 | Derived | Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AC Then T | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles |
| FG001 | AC Then XT | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AC Then T | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles |
| BG001 | AC Then XT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 [Number of Events] | Number of patients with/without recurrence of breast cancer, or death due to any cause. | Intent-to-Treat Population | Posted | Number | participants | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
Length of study
Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AC Then T | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Taxotere |
| Drug |
75mg/m2 iv on day 1 of each 3 week cycle |
|
| Taxotere | Drug | 100mg/m2 iv on day 1 of each 3 week cycle |
|
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive. |
| Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
| Breast Cancer Free Survival [Number of Events] | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. | Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years . |
| Breast Cancer Free Survival [Time to Event] | Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event | Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Disease Free Survival Including Any New Cancer as Event [Number of Events] | Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Disease Free Survival Including Any New Cancer as Event [Time to Event] | Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
| Lost to Follow-up |
|
Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival [Number of Events] | Number of patients who died/were alive. | Intent-to-Treat Population | Posted | Number | participants | Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
|
|
|
| Primary | Disease Free Survival [Time to Event] | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Overall Survival [Time to Event] | Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive. | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Breast Cancer Free Survival [Number of Events] | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. | Intent-to-Treat Population | Posted | Number | participants | Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years . |
|
|
|
| Secondary | Breast Cancer Free Survival [Time to Event] | Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause. | Intent-to-Treat Population | Posted | Number | participants | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event | Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Disease Free Survival Including Any New Cancer as Event [Number of Events] | Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause. | Intent-to-Treat Population | Posted | Number | participants | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| Secondary | Disease Free Survival Including Any New Cancer as Event [Time to Event] | Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | months | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
|
|
|
| 264 |
| 1,305 |
| 1,301 |
| 1,305 |
| EG001 | AC Then XT | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles | 200 | 1,283 | 1,283 | 1,283 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BREAST CELLULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BREAST INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BREAST ABSCESS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ABSCESS LIMB | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ACUTE SINUSITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| FEBRILE INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| HISTOPLASMOSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| MASTITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| MENINGITIS BACTERIAL | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PAROTITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PERIDIVERTICULAR ABSCESS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PLEURAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMONIA PRIMARY ATYPICAL | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| STOMATITIS ALL | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ENTEROCUTANEOUS FISTULA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| OESOPHAGITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| HERNIA OBSTRUCTIVE | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| THROMBOSIS IN DEVICE | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| CATHETER SITE PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHEST DISCOMFORT | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEVICE DISLOCATION | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| MEDICAL DEVICE COMPLICATION | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ALVEOLITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| AORTITIS | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| VENOUS OCCLUSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| COMPARTMENT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| CARDIOMYOPATHY ACUTE | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| BREAST MASS | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| MENOMETRORRHAGIA | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| VAGINAL LACERATION | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| BREAST RECONSTRUCTION | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| LYMPHADENECTOMY | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| NEOPLASM PROPHYLAXIS | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| PROPHYLAXIS | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| SIMPLE MASTECTOMY | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| METASTASES TO MENINGES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| BREAST PROSTHESIS USER | Social circumstances | MedDRA 13.0 | Systematic Assessment |
|
| STOMATITIS ALL | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| PALMAR-PLANTAR | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| CANDIDIASIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| LYMPHOEDEMA | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |