Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005619-88 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + cisplatin + docetaxel | Experimental | Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab was supplied as a sterile liquid in glass vials. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Baseline to the end of the study (up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palma de Mallorca | Balearic Islands | 07198 | Spain | |||
The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Cisplatin + Docetaxel | Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cisplatin | Drug | Bevacizumab was supplied as a sterile liquid in glass vials. |
|
| Docetaxel | Drug | Bevacizumab was supplied as a sterile liquid in glass vials. |
|
|
| Baseline to the end of the study (up to 4 years) |
| Duration of the Objective Response | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. | Baseline to the end of the study (up to 4 years) |
| Overall Survival | Overall survival is defined as the time from the first dose of study medication until death. | Baseline to the end of the study (up to 4 years) |
| 1-year Survival | The probability of surviving 1 year was estimated using the Kaplan-Meier method. | Baseline to 1 year |
| Cadiz |
| Cadiz |
| 11009 |
| Spain |
| Castellon | Castellon | 12002 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Alcalá de Henares | Madrid | 28805 | Spain |
| Madrid | Madrid | 28036 | Spain |
| Madrid | Madrid | 28935 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Palencia | Palencia | 34005 | Spain |
| Sagunto | Valencia | 46520 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valladolid | Valladolid | 47005 | Spain |
| Valladolid | Valladolid | 47010 | Spain |
| Zamora | Zamora | 49021 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population: All enrolled participants who received at least 1 treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Cisplatin + Docetaxel | Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 4 years) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. | Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations. | Posted | Number | Percentage of participants | Baseline to the end of the study (up to 4 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of the Objective Response | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. | Not Posted | Baseline to the end of the study (up to 4 years) | ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from the first dose of study medication until death. | Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | 1-year Survival | The probability of surviving 1 year was estimated using the Kaplan-Meier method. | Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to 1 year |
|
|
Not provided
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
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 | Bevacizumab + Cisplatin + Docetaxel | Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. | 26 | 49 | 48 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count increased | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Positron emission tomography | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased leukocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
| |
| Appendectomy | Surgical and medical procedures | MedDRA (8.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Reaction at the injection site | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased hemoglobin | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| High neutrophil count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased platelet count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated blood creatinine | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased leukocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Gamma glutamyltransferase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated alanine aminotransferase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased total protein | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased lymphocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Abnormal transaminases | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated blood urea | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Urinary urobilin | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased neutrophil count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated leukocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Increased blood alkaline phosphatase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated gamma glutamyl transferase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated blood lactate dehydrogenase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated blood bilirubin | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Blood urea | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased monocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Hipofonesis | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated triglycerides in blood | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated ferritin in serum | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Positron emission tomography | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Abnormal coagulation test | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Increased international normalised ratio | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Prolonged activated partial thromboplastin time | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased blood creatinine | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased calcium in blood | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| White blood count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Lymphocyte count | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Elevated aspartate aminotransferase | Investigations | MedDRA (8.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Parotiditis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
| |
| Appendectomy | Surgical and medical procedures | MedDRA (8.1) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Ungueal toxicity | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Cutaneous toxicity | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hyperpigmentation of the skin | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Bone marrow depression | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Amenorrhea | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypokalemia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hyperpotassemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Neuropathy | 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 |
| |
| Paresthesia | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Decreased consciousness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Edema | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Reaction at the injection site | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Back pain | 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 |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pain in one extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pain in the chest wall | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pain in sacrum | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Increased lacrimation | Eye disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Perforation of the nasal septum | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hiccupping | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Orthopnea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (8.1) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
|
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