Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H3E-MC-S080 | Other Identifier | Eli Lilly and Company |
Not provided
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An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel | Experimental |
| |
| B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Pathological Complete Response | pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy | surgery after eight 21-day cycles of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy | The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol. | Cycles 1-4 (21-day cycles) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prior anthracyclines as part of prior anticancer therapy.
Concurrent antitumor therapy.
Second primary malignancy.
Serious concomitant systemic disorder.
Pre-existing sensorial or motor neuropathy
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baden-Baden | 76532 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20732932 | Result | Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23. |
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The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed Plus Doxorubicin, Followed by Docetaxel | pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
| FG001 | Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed Plus Doxorubicin, Followed by Docetaxel | pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
| BG001 | Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel |
| 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 | Number of Participants With a Pathological Complete Response | pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy | Participants meeting the following criteria qualify for pathological tumor response:
| Posted | Number | participants | surgery after eight 21-day cycles of chemotherapy |
|
Not provided
Not provided
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 | Pemetrexed Plus Doxorubicin, Followed by Docetaxel | pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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 |
|---|---|
| D000068437 | Pemetrexed |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cyclophosphamide | Drug | 600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4) |
|
| doxorubicin | Drug | 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) |
|
| docetaxel | Drug | 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
|
| Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy |
The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol. |
| Cycles 5-8 (21-day cycles) |
| Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery | Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery. | surgery after eight 21-day cycles of chemotherapy |
| Disease-free Survival | Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date. | baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization) |
| Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | 10967 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | 20357 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heidelberg | D-69115 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cremona | 26100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rozzano | 20089 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moscow | 129128 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Petersburg | 197022 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jaén | 23007 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sabadell | 08208 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | 46010 | Spain |
| Physician Decision |
|
| Sponsor Decision |
|
| Progressive Disease |
|
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group Performance Status | Number | participants |
|
| Estrogen and Progesterone Receptor Status | Number | participants |
|
| Menopausal Status | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| OG001 | Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) |
|
|
|
| Secondary | Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy | The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol. | Participants meeting following criteria qualify for clinical tumor response:
| Posted | Number | participants | Cycles 1-4 (21-day cycles) |
|
|
|
| Secondary | Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy | The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol. | Participants meeting following criteria qualify for clinical tumor response:
| Posted | Number | participants | Cycles 5-8 (21-day cycles) |
|
|
|
| Secondary | Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery | Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery. | Participants meeting the following criteria qualify for pathological tumor response:
| Posted | Number | participants | surgery after eight 21-day cycles of chemotherapy |
|
|
|
| Secondary | Disease-free Survival | Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date. | All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored. | Posted | Feb 2012 | Median | 95% Confidence Interval | months | baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization) |
|
|
|
| 15 |
| 134 |
| 134 |
| 134 |
| EG001 | Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) | 25 | 123 | 120 | 123 |
| Chronic lymphocytic leukaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vascular encephalopathy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
|
| Axillary vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Post procedural haematoma | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 8.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| White blood cell count | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| 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 |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Stable Disease |
|
| Progressive Disease |
|
| Unknown |
|
| Not Done |
|
| Stable Disease |
|
| Progressive Disease |
|
| Unknown |
|
| Not Done |
|