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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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The purpose of this study is to determine if the addition of metformin to standard chemotherapy improves progression free survival in women with metastatic breast cancer.
A double blind Phase II randomized study of metformin versus (vs) placebo in non-diabetic women on first to fourth line chemotherapy with anthracycline, taxane, platinum, capecitabine or vinorelbine based regimens for metastatic or unresectable locally advanced breast cancer (BC). Patients were randomized to receive metformin 850 mg tablets or placebo once daily for two days as ramp-up, followed by one tablet twice a day for the duration of the study. Randomization was stratified by line of chemotherapy (1st, 2nd, 3rd and 4th line) and hormone receptor status (ER and/or PgR positive versus both negative). All patients were required to have measureable or non-measureable, but evaluable metastases at study entry. Metformin or placebo was to be continued until disease progression, even if chemotherapy was changed or stopped prior to disease progression. Recruitment took place at five sites in Ontario, Canada: Mount Sinai Hospital, Princess Margaret Cancer Centre, St. Michael's Hospital, Toronto and London Regional Cancer Centre, London.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). |
|
| Placebo | Placebo Comparator | Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: Until progression or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival. | Scans will be repeated every 9 weeks. Local follow up for survival will continue until all patients have died or for a maximum total follow up of 3 years, which ever occurs first. The two study arms will be compared in an intent to treat fashion using Cox proportional hazard analysis, with the stratification variables included in the model. Treatment discontinuation for toxicity or other reasons will be considered an event. | From date of randomization to first documented progression or death, which ever occurs first, assessed up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate in patients with measureable disease based upon RECIST Version 1.1. Patients will have scans repeated every 9 weeks and overall review of response across the study will be done every 6 months. The overall response rate is defined as number of patients with a best overall response of CR or PR, as a proportion of all patient with measurable disease at baseline. The response rate between arms will be compared using logistic regression with treatment as factor, adjusted for strata. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela J Goodwin, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Program | London | Ontario | Canada | |||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31472446 | Result | Pimentel I, Lohmann AE, Ennis M, Dowling RJO, Cescon D, Elser C, Potvin KR, Haq R, Hamm C, Chang MC, Stambolic V, Goodwin PJ. A phase II randomized clinical trial of the effect of metformin versus placebo on progression-free survival in women with metastatic breast cancer receiving standard chemotherapy. Breast. 2019 Dec;48:17-23. doi: 10.1016/j.breast.2019.08.003. Epub 2019 Aug 22. |
| Label | URL |
|---|---|
| Study Results | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: Until progression or unacceptable toxicity develops. |
| FG001 | Placebo | Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: until progression or unacceptable toxicity develops. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: Until progression or unacceptable toxicity develops. |
| 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 | Progression Free Survival. | Scans will be repeated every 9 weeks. Local follow up for survival will continue until all patients have died or for a maximum total follow up of 3 years, which ever occurs first. The two study arms will be compared in an intent to treat fashion using Cox proportional hazard analysis, with the stratification variables included in the model. Treatment discontinuation for toxicity or other reasons will be considered an event. | Posted | Mean | Standard Deviation | months | From date of randomization to first documented progression or death, which ever occurs first, assessed up to 3 years. |
|
The Adverse Events reporting period is defined as the time of consent signature until 30 days after date of off study treatment.
All-cause mortality is available on all subjects (metformin n=22, placebo n=18). All the other Adverse Events are available on patients that received study drug (metformin n=22, placebo n=17).
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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 | Metformin | Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Metformin: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: Until progression or unacceptable toxicity develops. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia with respiratory infection | Infections and infestations | CTCAE version 4 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
Limitations include relatively small sample size, with associated imbalances in frequency of visceral (vs nonvisceral) metastatic disease, in HER2 positive and negative cancers, and in type of chemotherapy received in the metformin vs placebo arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Goodwin/PI | Mount Sinai Hospital | 416 586-8211 | Pamela.goodwin@sinaihealth.ca |
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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: until progression or unacceptable toxicity develops. |
|
| From baseline until time of best response, assessed up to 3 years |
| Number of Participants With Grade 1 or 2 Adverse Events | Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Lower grade (grade 1 and 2) and higher grade (grade 3 and 4) are presented separately. A detailed breakdown of adverse events are given in the Adverse Events section | Up to 30 days after end of study |
| Number of Participants With Grade 3 or 4 Adverse Events | Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Lower grade (grade 1 and 2) and higher grade (grade 3 and 4) are presented separately. A detailed breakdown of adverse events are given in the Adverse Events section | Up to 30 days after end of study |
| EORTC Quality of Life Measures | European Organization for Research and Treatment of Cancer (EORTC) quality of life measures: global health status and 5 functioning scales. Baseline and Cycle 2 outcomes are scaled from 0 to 100; higher scores indicate better functioning or better health status. CHANGE in these scales from baseline to cycle 2 is reported for each arm. | From baseline to cycle 2 of chemotherapy |
| Change in Fasting Glucose (mmol/L) | Change in fasting glucose from baseline to Cycle 2 | Baseline to Cycle 2 |
| Change in Fasting Insulin | Change in fasting insulin from baseline to Cycle 2 | Baseline to Cycle 2 |
| Change in Insulin Resistance From Baseline to Cycle 2 Measured Using Homeostatic Model Assessment (HOMA-IR) | HOMA-IR is an index calculated from fasting insulin (pmol/L) and glucose (mmol/L) as insulin/6.9 times glucose/22.5. | Baseline to Cycle 2 |
| Immunohistochemical Predictors of Metformin Benefit and to Explore Changes in These Variables in Women Who Undergo Serial Biopsies of Their Metastases. | Immunohistochemical analysis of different markers (IR, LKB1, phosphorylated AKT, S6K, ribosomal protein S6, 4E-BP1, and stathmin) pre and post first cycle of chemotherapy with metformin as well as in the original tumour tissue. Change in the phospho-markers of PI3K/mTOR will be summarized before and after the first cycle of chemotherapy with a focus on detection between the study arms. | Baseline and 3 weeks. |
| Gene Expression Predictors of Potential Metformin Benefit Including Exploration of Changes in These Variables in Women Who Undergo Serial Biopsies of Their Metastases | Gene expression profiles in the baseline (original tumour) and, when available, pre and post cycle 1 chemotherapy will be established and change in gene signature pre and post chemotherapy will be explored. | Baseline and 4 weeks |
| Toronto |
| Ontario |
| M5B 1N9 |
| Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| BG001 |
| Placebo |
Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: until progression or unacceptable toxicity develops. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Based on National Institutes of Health (NIH) Office of Management and Budget (OMB) Standards | Count of Participants | Participants |
|
| ECOG Performance Scale | Eastern Cooperative Oncology Group (ECOG) Performance Scale. Developed by the Eastern Cooperative Oncology Group, 1982 - Robert L. Comis, MD, Group Chair. Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Receptor Status | Number | participants |
|
| Human epidermal growth factor receptor 2 (HER2) status | Number | participants |
|
| Any adjuvant chemotherapy | Number | participants |
|
| 1st diagnosis to randomization | Mean | Full Range | years |
|
| 1st metastasis to randomization | Mean | Full Range | years |
|
| Line of treatment | Number | participants |
|
| Any visceral disease | Number | participants |
|
| Involvement beyond bone and lymph nodes | Number | participants |
|
| OG001 | Placebo | Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: until progression or unacceptable toxicity develops. |
|
|
|
| Secondary | Overall Response Rate | Overall response rate in patients with measureable disease based upon RECIST Version 1.1. Patients will have scans repeated every 9 weeks and overall review of response across the study will be done every 6 months. The overall response rate is defined as number of patients with a best overall response of CR or PR, as a proportion of all patient with measurable disease at baseline. The response rate between arms will be compared using logistic regression with treatment as factor, adjusted for strata. | Population is everyone with measurable disease (metformin 22, placebo 16) | Posted | Count of Participants | Participants | From baseline until time of best response, assessed up to 3 years |
|
|
|
|
| Secondary | Number of Participants With Grade 1 or 2 Adverse Events | Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Lower grade (grade 1 and 2) and higher grade (grade 3 and 4) are presented separately. A detailed breakdown of adverse events are given in the Adverse Events section | Population is everyone who received study drug (metformin n=22, placebo n=17). | Posted | Count of Participants | Participants | Up to 30 days after end of study |
|
|
|
| Secondary | Number of Participants With Grade 3 or 4 Adverse Events | Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Lower grade (grade 1 and 2) and higher grade (grade 3 and 4) are presented separately. A detailed breakdown of adverse events are given in the Adverse Events section | Population is everyone who received study drug (metformin n=22, placebo n=17). | Posted | Count of Participants | Participants | Up to 30 days after end of study |
|
|
|
| Secondary | EORTC Quality of Life Measures | European Organization for Research and Treatment of Cancer (EORTC) quality of life measures: global health status and 5 functioning scales. Baseline and Cycle 2 outcomes are scaled from 0 to 100; higher scores indicate better functioning or better health status. CHANGE in these scales from baseline to cycle 2 is reported for each arm. | Population is everyone who completed BOTH baseline and Cycle 2 questionnaires (19 metformin, 16 placebo). 3 metformin and 2 placebo patients did not complete the Cycle 2 EORTC questionnaire. | Posted | Mean | Standard Deviation | EORTC functioning scale | From baseline to cycle 2 of chemotherapy |
|
|
|
| Secondary | Change in Fasting Glucose (mmol/L) | Change in fasting glucose from baseline to Cycle 2 | Population is everyone who had institutional glucose performed at BOTH baseline and Cycle 2 (19 metformin, 15 placebo). | Posted | Median | Inter-Quartile Range | mmol/L | Baseline to Cycle 2 |
|
|
|
| Secondary | Change in Fasting Insulin | Change in fasting insulin from baseline to Cycle 2 | Population is everyone who had sufficient fasting blood available for analysis at BOTH baseline and Cycle 2 (12 metformin, 7 placebo). | Posted | Median | Inter-Quartile Range | pmol/L | Baseline to Cycle 2 |
|
|
|
| Secondary | Change in Insulin Resistance From Baseline to Cycle 2 Measured Using Homeostatic Model Assessment (HOMA-IR) | HOMA-IR is an index calculated from fasting insulin (pmol/L) and glucose (mmol/L) as insulin/6.9 times glucose/22.5. | Population is everyone who had sufficient fasting blood available for analysis at BOTH baseline and Cycle 2 (12 metformin, 7 placebo). | Posted | Median | Inter-Quartile Range | HOMA-IR score | Baseline to Cycle 2 |
|
|
|
| Secondary | Immunohistochemical Predictors of Metformin Benefit and to Explore Changes in These Variables in Women Who Undergo Serial Biopsies of Their Metastases. | Immunohistochemical analysis of different markers (IR, LKB1, phosphorylated AKT, S6K, ribosomal protein S6, 4E-BP1, and stathmin) pre and post first cycle of chemotherapy with metformin as well as in the original tumour tissue. Change in the phospho-markers of PI3K/mTOR will be summarized before and after the first cycle of chemotherapy with a focus on detection between the study arms. | Data not collected | Posted | Baseline and 3 weeks. |
|
|
| Secondary | Gene Expression Predictors of Potential Metformin Benefit Including Exploration of Changes in These Variables in Women Who Undergo Serial Biopsies of Their Metastases | Gene expression profiles in the baseline (original tumour) and, when available, pre and post cycle 1 chemotherapy will be established and change in gene signature pre and post chemotherapy will be explored. | Data not collected | Posted | Baseline and 4 weeks |
|
|
| 19 |
| 22 |
| 3 |
| 22 |
| 22 |
| 22 |
| EG001 | Placebo | Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Placebo: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). Number of cycles: until progression or unacceptable toxicity develops. | 15 | 18 | 4 | 17 | 15 | 17 |
| urosepsis | Infections and infestations | CTCAE version 4 | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| febrile neutropenia with urinary tract infection | Infections and infestations | CTCAE version 4 | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| ascites with hyponatraemia | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| thromboembolism | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| DYSGEUSIA | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| EPIGASTRIC DISCOMFORT | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAE version 4 | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE version 4 | Systematic Assessment |
|
| HOT FLUSH | General disorders | CTCAE version 4 | Systematic Assessment |
|
| PYREXIA | General disorders | CTCAE version 4 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | CTCAE version 4 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | CTCAE version 4 | Systematic Assessment |
|
| CHILLS | General disorders | CTCAE version 4 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | CTCAE version 4 | Systematic Assessment |
|
| LOCALISED OEDEMA | General disorders | CTCAE version 4 | Systematic Assessment |
|
| PAIN | General disorders | CTCAE version 4 | Systematic Assessment |
|
| ASTHENIA | General disorders | CTCAE version 4 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| INSOMNIA | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| VISION BLURRED | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| CARPAL TUNNEL SYNDROME | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPOAESTHESIA EYE | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | CTCAE version 4 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | CTCAE version 4 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| NAIL DISORDER | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| SKIN INFECTION | Skin and subcutaneous tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | CTCAE version 4 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| DIZZINESS | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| EPISTAXIS | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| EMBOLISM | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Vascular disorders | CTCAE version 4 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | CTCAE version 4 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | Metabolism and nutrition disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | CTCAE version 4 | Systematic Assessment |
|
| LOCALISED OEDEMA | Metabolism and nutrition disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | CTCAE version 4 | Systematic Assessment |
|
| DYSPNOEA | Cardiac disorders | CTCAE version 4 | Systematic Assessment |
|
| DIZZINESS | Cardiac disorders | CTCAE version 4 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | Cardiac disorders | CTCAE version 4 | Systematic Assessment |
|
| LOCALISED OEDEMA | Cardiac disorders | CTCAE version 4 | Systematic Assessment |
|
| SKIN INFECTION | Infections and infestations | CTCAE version 4 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | CTCAE version 4 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPOAESTHESIA EYE | Eye disorders | CTCAE version 4 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | CTCAE version 4 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAE version 4 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAE version 4 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAE version 4 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | CTCAE version 4 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | CTCAE version 4 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | CTCAE version 4 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | CTCAE version 4 | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Psychiatric disorders | CTCAE version 4 | Systematic Assessment |
|
| HOT FLUSH | Reproductive system and breast disorders | CTCAE version 4 | Systematic Assessment |
|
| BREAST PAIN | Reproductive system and breast disorders | CTCAE version 4 | Systematic Assessment |
|
| VULVOVAGINAL DRYNESS | Reproductive system and breast disorders | CTCAE version 4 | Systematic Assessment |
|
| PHLEBITIS | Injury, poisoning and procedural complications | CTCAE version 4 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | CTCAE version 4 | Systematic Assessment |
|
| CYSTITIS | Renal and urinary disorders | CTCAE version 4 | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Endocrine disorders | CTCAE version 4 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | CTCAE version 4 | Systematic Assessment |
|
| HEARING IMPAIRED | Ear and labyrinth disorders | CTCAE version 4 | Systematic Assessment |
|
| SYNOVIAL CYST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4 | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Role functioning |
|
| Emotional functioning |
|
| Cognitive functioning |
|
| Social functioning |
|