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Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
The study included:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel and Bevacizumab | Experimental | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
|
| Docetaxel, Bevacizumab and Trastuzumab | Experimental | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Rate: Percentage of Participants With PFS | PFS was the time from registration to first documentation of
The Percentage of participants with PFS is reported. For the analysis, participants were censored
| Up to 6 months and 12 months after treatment initiation |
| Time to Progression-free Survival (PFS) | Time to PFS was the interval from the date of registration to the earliest of the following documented dates:
Time to PFS was estimated from Kaplan-Meier Plots. | From treatment initiation to PFS event (up to June 2011) |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Overall Response (OR) Based on RECIST Criteria | Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST
To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required. |
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The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Barry Childs, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
103 participants signed the informed consent for this study. Of these, 73 were determined to be eligible for inclusion. One participant did not receive any study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel and Bevacizumab | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| FG001 | Docetaxel, Bevacizumab and Trastuzumab | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel and Bevacizumab | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| BG001 |
| 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 (PFS) Rate: Percentage of Participants With PFS | PFS was the time from registration to first documentation of
The Percentage of participants with PFS is reported. For the analysis, participants were censored
| Intent to treat population: all registered participants | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 months and 12 months after treatment initiation |
|
From treatment initiation up to 30 days following the last dose of study medication (upto April 2012)
All participants (except one) were off study treatment on 30 June 2011. An initial safety analysis was performed using the cut-off date of June 2011. One participant continued till 19 April 2012. For this participant, adverse events were collected upto April 2012 and included in the final safety analysis.
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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 | Docetaxel and Bevacizumab | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi-aventis | Contact-us@sanofi.com |
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 |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| Docetaxel | Drug | Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w |
|
| Trastuzumab | Drug |
|
|
|
| From treatment initiation to June 2011 |
| Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria | Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD). According to RECIST
Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD). | From treatment initiation to June 2011 |
| Duration of Response (DR) | DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression. Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy. DR was estimated from Kaplan-Meier Plots. | From treatment initiation to June 2011 |
| Overall Survival (OS) Time | OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. OS time was estimated from Kaplan-Meier Plots. | From treatment initiation to June 2011 |
| Number of Participants With Adverse Events (AE) | An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs). An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important. | From treatment initiation to 30 days after the last dose of study treatment |
| Participant's Request |
|
| Disease Progression |
|
| Investigator decision |
|
| Found Ineligible |
|
| Presumed CR on Study |
|
| Receiving Liver Ablation |
|
| Docetaxel, Bevacizumab and Trastuzumab |
Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Eastern Cooperative Oncology | The ECOG performance status score is used to assess how a patient's disease is progressing and to assess how the disease affects the patient's daily living abilities. The ECOG score ranges from 0-5, with 0 indicating the best outcome and a score of 5 indicating the worst outcome. An ECOG score "0" reflects a fully active patient, able to carry on all pre-disease performance without restriction. An ECOG score "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. | Number | participants |
|
Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| OG001 | Docetaxel, Bevacizumab and Trastuzumab | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
|
|
| Primary | Time to Progression-free Survival (PFS) | Time to PFS was the interval from the date of registration to the earliest of the following documented dates:
Time to PFS was estimated from Kaplan-Meier Plots. | Intent-to-treat population: all registered participants | Posted | Median | 95% Confidence Interval | days | From treatment initiation to PFS event (up to June 2011) | PFS events analyzed | Participants |
|
|
|
| Secondary | Confirmed Overall Response (OR) Based on RECIST Criteria | Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST
To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required. | Intent-to-treat population: all registered participants. | Posted | Number | participants | From treatment initiation to June 2011 |
|
|
|
| Secondary | Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria | Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD). According to RECIST
Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD). | Intent-to-treat: all registered participants. | Posted | Number | participants | From treatment initiation to June 2011 |
|
|
|
| Secondary | Duration of Response (DR) | DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression. Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy. DR was estimated from Kaplan-Meier Plots. | Participants with a documented response of CR or PR. | Posted | Median | 95% Confidence Interval | days | From treatment initiation to June 2011 | Events (PD or death after 1st Response) | Participants |
|
|
|
| Secondary | Overall Survival (OS) Time | OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. OS time was estimated from Kaplan-Meier Plots. | Intent-to-treat population: all registered participants. | Posted | Median | Inter-Quartile Range | days | From treatment initiation to June 2011 | Deaths | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) | An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs). An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important. | Safety population: all participants who received at least one dose of study medication | Posted | Number | participants | From treatment initiation to 30 days after the last dose of study treatment |
|
|
|
| 14 |
| 52 |
| 52 |
| 52 |
| EG001 | Docetaxel, Bevacizumab and Trastuzumab | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met | 4 | 20 | 20 | 20 |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Peridiverticular abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study for review and comment at least 60 days in advance of any submission for publication. The Sponsor may request for the publication to be delayed for a limited time, not to exceed 90 days to preserve its proprietary rights.
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Confirmed partial response |
|
| with confirmed PR |
|
| with confirmed SD |
|
| with TEAEs resulting in death |
|