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A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

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ClinicalTrials.gov Identifier: NCT00448591
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: Taxane-based chemotherapy
Enrollment 2296
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
Period Title: Overall Study
Started 2296
Completed 0
Not Completed 2296
Reason Not Completed
Withdrawal by Subject             178
Progressive Disease             1382
Adverse Event             382
Protocol Violation             41
Lost to Follow-up             19
Treatment Regimen Completed             70
Not specified             154
Termination of Study             70
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
Overall Number of Baseline Participants 2264
Hide Baseline Analysis Population Description
The safety/intent-to-treat (ITT) population was defined as all participants who had signed informed consent, with at least one valid post-baseline assessment and who received at least one dose of bevacizumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2264 participants
53.2  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2264 participants
Female
2252
  99.5%
Male
12
   0.5%
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)
Hide Description Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.
Time Frame Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 95.4
CTC grade 3, 4 or 5 AE 57.6
Bevacizumab-related AE 64.2
Any Serious AE 29.7
Bevacizumab-related serious SAE 7.6
All deaths 53.1
AESIs 71.8
2.Secondary Outcome
Title Percentage of Participants With Disease Progression
Hide Description Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time Frame Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Measure Type: Number
Unit of Measure: percentage of participants
72.44
3.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.
Time Frame Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Median (Full Range)
Unit of Measure: months
9.7
(9.4 to 10.1)
4.Secondary Outcome
Title Percentage of Participants With Recorded Death
Hide Description [Not Specified]
Time Frame Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Measure Type: Number
Unit of Measure: percentage of participants
53.14
5.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.
Time Frame Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Median (Full Range)
Unit of Measure: months
25.2
(24.0 to 26.3)
6.Secondary Outcome
Title Percentage of Participants by Best Overall Response to Treatment
Hide Description Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.
Time Frame Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
Overall Number of Participants Analyzed 2264
Measure Type: Number
Unit of Measure: percentage of participants
Complete response 9.0
Partial response 45.1
Stable disease 32.4
Progressive disease 9.1
Not evaluable 0.1
Assessment not done 4.2
Time Frame Adverse events were recorded throughout the study from date of first dose of drug administration until follow up visits.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   672/2264 (29.68%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  117/2264 (5.17%) 
Neutropenia * 1  98/2264 (4.33%) 
Febrile bone marrow aplasia * 1  14/2264 (0.62%) 
Anaemia * 1  8/2264 (0.35%) 
Leukopenia * 1  8/2264 (0.35%) 
Thrombocytopenia * 1  6/2264 (0.27%) 
Disseminated intravascular coagulation * 1  3/2264 (0.13%) 
Agranulocytosis * 1  1/2264 (0.04%) 
Bone marrow failure * 1  1/2264 (0.04%) 
Lymphopenia * 1  1/2264 (0.04%) 
Thrombotic microangiopathy * 1  1/2264 (0.04%) 
Thrombotic thrombocytopenic purpura * 1  1/2264 (0.04%) 
Cardiac disorders   
Cardiac failure * 1  4/2264 (0.18%) 
Cardiac failure congestive * 1  4/2264 (0.18%) 
Myocardial infarction * 1  4/2264 (0.18%) 
Atrial fibrillation * 1  3/2264 (0.13%) 
Angina unstable * 1  2/2264 (0.09%) 
Cardiac arrest * 1  2/2264 (0.09%) 
Palpitations * 1  2/2264 (0.09%) 
Acute myocardial infarction * 1  1/2264 (0.04%) 
Arrhythmia * 1  1/2264 (0.04%) 
Atrial flutter * 1  1/2264 (0.04%) 
Cardiogenic shock * 1  1/2264 (0.04%) 
Cardiomyopathy * 1  1/2264 (0.04%) 
Cardiotoxicity * 1  1/2264 (0.04%) 
Congestive cardiomyopathy * 1  1/2264 (0.04%) 
Coronary artery disease * 1  1/2264 (0.04%) 
Diastolic dysfunction * 1  1/2264 (0.04%) 
Myocardial ischaemia * 1  1/2264 (0.04%) 
Pericardial effusion * 1  1/2264 (0.04%) 
Sinus tachycardia * 1  1/2264 (0.04%) 
Tachycardia * 1  1/2264 (0.04%) 
Ventricular arrhythmia * 1  1/2264 (0.04%) 
Ear and labyrinth disorders   
Deafness * 1  2/2264 (0.09%) 
Eye disorders   
Diplopia * 1  2/2264 (0.09%) 
Blindness * 1  1/2264 (0.04%) 
Keratitis * 1  1/2264 (0.04%) 
Pupils unequal * 1  1/2264 (0.04%) 
Retinal detachment * 1  1/2264 (0.04%) 
Gastrointestinal disorders   
Vomiting * 1  20/2264 (0.88%) 
Diarrhoea * 1  13/2264 (0.57%) 
Gastrointestinal haemorrhage * 1  9/2264 (0.40%) 
Abdominal pain * 1  7/2264 (0.31%) 
Nausea * 1  6/2264 (0.27%) 
Constipation * 1  5/2264 (0.22%) 
Rectal haemorrhage * 1  4/2264 (0.18%) 
Stomatitis * 1  4/2264 (0.18%) 
Anal fistula * 1  3/2264 (0.13%) 
Gastrointestinal perforation * 1  3/2264 (0.13%) 
Subileus * 1  3/2264 (0.13%) 
Ascites * 1  2/2264 (0.09%) 
Colitis * 1  2/2264 (0.09%) 
Diarrhoea haemorrhagic * 1  2/2264 (0.09%) 
Haematemesis * 1  2/2264 (0.09%) 
Intestinal perforation * 1  2/2264 (0.09%) 
Large intestine perforation * 1  2/2264 (0.09%) 
Peritonitis * 1  2/2264 (0.09%) 
Abdominal pain upper * 1  1/2264 (0.04%) 
Anal fissure * 1  1/2264 (0.04%) 
Colitis ulcerative * 1  1/2264 (0.04%) 
Dental caries * 1  1/2264 (0.04%) 
Diverticulum intestinal haemorrhagic * 1  1/2264 (0.04%) 
Duodenal perforation * 1  1/2264 (0.04%) 
Duodenal ulcer * 1  1/2264 (0.04%) 
Dysphagia * 1  1/2264 (0.04%) 
Enteritis * 1  1/2264 (0.04%) 
Gastric haemorrhage * 1  1/2264 (0.04%) 
Gastric perforation * 1  1/2264 (0.04%) 
Gastritis * 1  1/2264 (0.04%) 
Gastrointestinal disorder * 1  1/2264 (0.04%) 
Gastrointestinal obstruction * 1  1/2264 (0.04%) 
Gastrointestinal pain * 1  1/2264 (0.04%) 
Gastrointestinal toxicity * 1  1/2264 (0.04%) 
Gingivitis * 1  1/2264 (0.04%) 
Haematochezia * 1  1/2264 (0.04%) 
Ileal perforation * 1  1/2264 (0.04%) 
Intestinal obstruction * 1  1/2264 (0.04%) 
Irritable bowel syndrome * 1  1/2264 (0.04%) 
Lower gastrointestinal haemorrhage * 1  1/2264 (0.04%) 
Melaena * 1  1/2264 (0.04%) 
Oesophageal fistula * 1  1/2264 (0.04%) 
Oesophageal stenosis * 1  1/2264 (0.04%) 
Oesophagitis * 1  1/2264 (0.04%) 
Pancreatitis * 1  1/2264 (0.04%) 
Pneumoperitoneum * 1  1/2264 (0.04%) 
Proctalgia * 1  1/2264 (0.04%) 
Proctocolitis * 1  1/2264 (0.04%) 
Sigmoiditis * 1  1/2264 (0.04%) 
General disorders   
Pyrexia * 1  26/2264 (1.15%) 
Impaired healing * 1  9/2264 (0.40%) 
Chest pain * 1  6/2264 (0.27%) 
General physical health deterioration * 1  6/2264 (0.27%) 
Asthenia * 1  5/2264 (0.22%) 
Fatigue * 1  3/2264 (0.13%) 
Malaise * 1  3/2264 (0.13%) 
Pain * 1  3/2264 (0.13%) 
Death * 1  2/2264 (0.09%) 
Oedema peripheral * 1  2/2264 (0.09%) 
Aplasia * 1  1/2264 (0.04%) 
Discomfort * 1  1/2264 (0.04%) 
Extravasation * 1  1/2264 (0.04%) 
Hyperthermia * 1  1/2264 (0.04%) 
Mucosal inflammation * 1  1/2264 (0.04%) 
Necrosis * 1  1/2264 (0.04%) 
Pelvic mass * 1  1/2264 (0.04%) 
Hepatobiliary disorders   
Cholecystitis * 1  3/2264 (0.13%) 
Hepatic failure * 1  3/2264 (0.13%) 
Hyperbilirubinaemia * 1  3/2264 (0.13%) 
Cholangitis * 1  1/2264 (0.04%) 
Cholecystitis acute * 1  1/2264 (0.04%) 
Hepatic atrophy * 1  1/2264 (0.04%) 
Hepatic functional abnormal * 1  1/2264 (0.04%) 
Hepatitis toxic * 1  1/2264 (0.04%) 
Hepatotoxicity * 1  1/2264 (0.04%) 
Jaundice hepatocellular * 1  1/2264 (0.04%) 
Portal vein thrombosis * 1  1/2264 (0.04%) 
Immune system disorders   
Hypersensitivity * 1  3/2264 (0.13%) 
Infections and infestations   
Pneumonia * 1  17/2264 (0.75%) 
Infection * 1  15/2264 (0.66%) 
Sepsis * 1  17/2264 (0.75%) 
Device related infection * 1  16/2264 (0.71%) 
Urinary tract infection * 1  9/2264 (0.40%) 
Neutropenic sepsis * 1  8/2264 (0.35%) 
Anal abscess * 1  5/2264 (0.22%) 
Abscess limb * 1  4/2264 (0.18%) 
Diverticulitis * 1  4/2264 (0.18%) 
Erysipelas * 1  4/2264 (0.18%) 
Bronchitis * 1  3/2264 (0.13%) 
Cellulitis * 1  3/2264 (0.13%) 
Febrile infection * 1  3/2264 (0.13%) 
Lower respiratory infection * 1  3/2264 (0.13%) 
Abscess * 1  2/2264 (0.09%) 
Appendicitis * 1  2/2264 (0.09%) 
Catheter site infection * 1  2/2264 (0.09%) 
Herpes zoster * 1  2/2264 (0.09%) 
Lung infection * 1  2/2264 (0.09%) 
Soft tissue infection * 1  2/2264 (0.09%) 
Abscess soft tissue * 1  1/2264 (0.04%) 
Anal infection * 1  1/2264 (0.04%) 
Arthritis infective * 1  1/2264 (0.04%) 
Catheter sepsis * 1  1/2264 (0.04%) 
Clostridial infection * 1  1/2264 (0.04%) 
Clostridium difficile colitis * 1  1/2264 (0.04%) 
Endocarditis * 1  1/2264 (0.04%) 
Escherichia infection * 1  1/2264 (0.04%) 
Gastroenteritis * 1  1/2264 (0.04%) 
Gastrointestinal infection * 1  1/2264 (0.04%) 
Infected cyst * 1  1/2264 (0.04%) 
Influenza * 1  1/2264 (0.04%) 
Kidney infection * 1  1/2264 (0.04%) 
Klebsiella sepsis * 1  1/2264 (0.04%) 
Laryngitis * 1  1/2264 (0.04%) 
Liver abscess * 1  1/2264 (0.04%) 
Neutropenic infection * 1  1/2264 (0.04%) 
Osteomyelitis * 1  1/2264 (0.04%) 
Otitis media * 1  1/2264 (0.04%) 
Parotid abscess * 1  1/2264 (0.04%) 
Perianal abscess * 1  1/2264 (0.04%) 
Periodontal infection * 1  1/2264 (0.04%) 
Peritonsillar abscess * 1  1/2264 (0.04%) 
Postoperative wound infection * 1  1/2264 (0.04%) 
Pseudomonas infection * 1  1/2264 (0.04%) 
Pyelonephritis * 1  1/2264 (0.04%) 
Renal cyst infection * 1  1/2264 (0.04%) 
Respiratory moniliasis * 1  1/2264 (0.04%) 
Septic shock * 1  1/2264 (0.04%) 
Sinusitis * 1  1/2264 (0.04%) 
Skin infection * 1  1/2264 (0.04%) 
Staphylococcal sepsis * 1  1/2264 (0.04%) 
Tonsillitis * 1  1/2264 (0.04%) 
Tooth infection * 1  1/2264 (0.04%) 
Tuberculous pleurisy * 1  1/2264 (0.04%) 
Upper respiratory tract infection * 1  1/2264 (0.04%) 
Urosepsis * 1  1/2264 (0.04%) 
Varicella * 1  1/2264 (0.04%) 
Viral infection * 1  1/2264 (0.04%) 
Wound abscess * 1  1/2264 (0.04%) 
Injury, poisoning and procedural complications   
Fall * 1  4/2264 (0.18%) 
Humerus fracture * 1  3/2264 (0.13%) 
Femoral neck fracture * 1  2/2264 (0.09%) 
Femur fracture * 1  2/2264 (0.09%) 
Head injury * 1  2/2264 (0.09%) 
Joint dislocation * 1  2/2264 (0.09%) 
Procedural pain * 1  2/2264 (0.09%) 
Contusion * 1  1/2264 (0.04%) 
Device breakage * 1  1/2264 (0.04%) 
Device leakage * 1  1/2264 (0.04%) 
Fracture * 1  1/2264 (0.04%) 
Haemothorax * 1  1/2264 (0.04%) 
Hepatic rupture * 1  1/2264 (0.04%) 
Lumbar vertebral fracture * 1  1/2264 (0.04%) 
Medical device complication * 1  1/2264 (0.04%) 
Patella fracture * 1  1/2264 (0.04%) 
Procedural complication * 1  1/2264 (0.04%) 
Radiation injury * 1  1/2264 (0.04%) 
Radiation oesophagitis * 1  1/2264 (0.04%) 
Radius fracture * 1  1/2264 (0.04%) 
Rib fracture * 1  1/2264 (0.04%) 
Subcutaneous haematoma * 1  1/2264 (0.04%) 
Thrombosis in device * 1  1/2264 (0.04%) 
Wound * 1  1/2264 (0.04%) 
Wound dehiscence * 1  1/2264 (0.04%) 
Investigations   
Neutrophil count decreased * 1  3/2264 (0.13%) 
White blood cell count decreased * 1  4/2264 (0.18%) 
Haemoglobin decreased * 1  2/2264 (0.09%) 
Platelet count decreased * 1  2/2264 (0.09%) 
Transaminases increased * 1  2/2264 (0.09%) 
Granulocyte count decreased * 1  1/2264 (0.04%) 
Neutrophil count abnormal * 1  1/2264 (0.04%) 
Scan myocardial perfusion abnormal * 1  1/2264 (0.04%) 
White blood cell count abnormal * 1  1/2264 (0.04%) 
Metabolism and nutrition disorders   
Dehydration * 1  5/2264 (0.22%) 
Hypercalcaemia * 1  4/2264 (0.18%) 
Hypokalaemia * 1  3/2264 (0.13%) 
Anorexia * 1  2/2264 (0.09%) 
Metabolic acidosis * 1  2/2264 (0.09%) 
Diabetes mellitus * 1  1/2264 (0.04%) 
Gout * 1  1/2264 (0.04%) 
Hyperkalaemia * 1  1/2264 (0.04%) 
Hypernatraemia * 1  1/2264 (0.04%) 
Hypocalcaemia * 1  1/2264 (0.04%) 
Hypoglycaemia * 1  1/2264 (0.04%) 
Hyponatraemia * 1  1/2264 (0.04%) 
Hypovolaemia * 1  1/2264 (0.04%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  8/2264 (0.35%) 
Osteonecrosis * 1  6/2264 (0.27%) 
Musculoskeletal pain * 1  4/2264 (0.18%) 
Pathological fracture * 1  3/2264 (0.13%) 
Bone pain * 1  2/2264 (0.09%) 
Pain in extremity * 1  2/2264 (0.09%) 
Arthralgia * 1  1/2264 (0.04%) 
Bone disorder * 1  1/2264 (0.04%) 
Fistula * 1  1/2264 (0.04%) 
Joint destruction * 1  1/2264 (0.04%) 
Neck pain * 1  1/2264 (0.04%) 
Osteitis * 1  1/2264 (0.04%) 
Osteoarthritis * 1  1/2264 (0.04%) 
Osteolysis * 1  1/2264 (0.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  1/2264 (0.04%) 
Cervix carcinoma * 1  1/2264 (0.04%) 
Metastases to bladder * 1  1/2264 (0.04%) 
Metastases to meninges * 1  1/2264 (0.04%) 
Uterine leiomyoma * 1  1/2264 (0.04%) 
Uterine prolapse * 1  1/2264 (0.04%) 
Nervous system disorders   
Headache * 1  6/2264 (0.27%) 
Cerebrovascular accident * 1  4/2264 (0.18%) 
Convulsion * 1  3/2264 (0.13%) 
Facial palsy * 1  3/2264 (0.13%) 
Cerebral haemorrhage * 1  2/2264 (0.09%) 
Dizziness * 1  2/2264 (0.09%) 
Hemiparesis * 1  2/2264 (0.09%) 
Neuropathy peripheral * 1  2/2264 (0.09%) 
Paraesthesia * 1  2/2264 (0.09%) 
Syncope * 1  2/2264 (0.09%) 
Transient ischaemic attack * 1  2/2264 (0.09%) 
Cerebral ischaemia * 1  1/2264 (0.04%) 
Cerebral microangiopathy * 1  1/2264 (0.04%) 
Cranial nerve paralysis * 1  1/2264 (0.04%) 
Dementia alzheimer's type * 1  1/2264 (0.04%) 
Epilepsy * 1  1/2264 (0.04%) 
Intracranial pressure increased * 1  1/2264 (0.04%) 
Movement disorder * 1  1/2264 (0.04%) 
Optic neuritis retrobulbar * 1  1/2264 (0.04%) 
Paraplegia * 1  1/2264 (0.04%) 
Peripheral motor neuropathy * 1  1/2264 (0.04%) 
Pneumocephalus * 1  1/2264 (0.04%) 
Presyncope * 1  1/2264 (0.04%) 
Reversible ischaemic neurological deficit * 1  1/2264 (0.04%) 
Psychiatric disorders   
Depression * 1  4/2264 (0.18%) 
Confusional state * 1  2/2264 (0.09%) 
Acute psychosis * 1  1/2264 (0.04%) 
Drug abuse * 1  1/2264 (0.04%) 
Insomnia related to another mental condition * 1  1/2264 (0.04%) 
Major depression * 1  1/2264 (0.04%) 
Mental disorder * 1  1/2264 (0.04%) 
Renal and urinary disorders   
Proteinuria * 1  5/2264 (0.22%) 
Nephrotic syndrome * 1  3/2264 (0.13%) 
Renal failure * 1  3/2264 (0.13%) 
Haematuria * 1  2/2264 (0.09%) 
Hydronephrosis * 1  1/2264 (0.04%) 
Hydroureter * 1  1/2264 (0.04%) 
Obstrucive uropathy * 1  1/2264 (0.04%) 
Renal colic * 1  1/2264 (0.04%) 
Ureteric obstruction * 1  1/2264 (0.04%) 
Urethral pain * 1  1/2264 (0.04%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/2264 (0.04%) 
Uterine disorder * 1  1/2264 (0.04%) 
Uterine haemorrhage * 1  1/2264 (0.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  23/2264 (1.02%) 
Pulmonary embolism * 1  21/2264 (0.93%) 
Epistaxis * 1  9/2264 (0.40%) 
Pleural effusion * 1  9/2264 (0.40%) 
Pneumothorax * 1  6/2264 (0.27%) 
Haemoptysis * 1  5/2264 (0.22%) 
Lung disorder * 1  3/2264 (0.13%) 
Nasal septum perforation * 1  3/2264 (0.13%) 
Pulmonary oedema * 1  2/2264 (0.09%) 
Respiratory failure * 1  2/2264 (0.09%) 
Aspiration * 1  1/2264 (0.04%) 
Dyspnoea exertional * 1  1/2264 (0.04%) 
Hypoventilation * 1  1/2264 (0.04%) 
Hypoxia * 1  1/2264 (0.04%) 
Non-cardiogenic pulmonary oedema * 1  1/2264 (0.04%) 
Pharyngeal inflammation * 1  1/2264 (0.04%) 
Pneumonia aspiration * 1  1/2264 (0.04%) 
Pulmonary infarction * 1  1/2264 (0.04%) 
Pulmonary thrombosis * 1  1/2264 (0.04%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome * 1  2/2264 (0.09%) 
Skin ulcer * 1  2/2264 (0.09%) 
Drug eruption * 1  1/2264 (0.04%) 
Intertrigo * 1  1/2264 (0.04%) 
Leukocytoclastic vasculitis * 1  1/2264 (0.04%) 
Pruritus * 1  1/2264 (0.04%) 
Skin necrosis * 1  1/2264 (0.04%) 
Skin toxicity * 1  1/2264 (0.04%) 
Surgical and medical procedures   
Mastectomy * 1  3/2264 (0.13%) 
Hepatectomy * 1  2/2264 (0.09%) 
Breast lump removal * 1  1/2264 (0.04%) 
Catheter removal * 1  1/2264 (0.04%) 
Hip surgery * 1  1/2264 (0.04%) 
Laryngeal operation * 1  1/2264 (0.04%) 
Thoractomy * 1  1/2264 (0.04%) 
Vascular disorders   
Hypertension * 1  16/2264 (0.71%) 
Deep vein thrombosis * 1  12/2264 (0.53%) 
Thrombosis * 1  4/2264 (0.18%) 
Venous thrombosis limb * 1  4/2264 (0.18%) 
Haemorrhage * 1  3/2264 (0.13%) 
Hypertensive crisis * 1  3/2264 (0.13%) 
Peripheral ischaemia * 1  2/2264 (0.09%) 
Phlebitis * 1  2/2264 (0.09%) 
Venous thrombosis * 1  2/2264 (0.09%) 
Aortic stenosis * 1  1/2264 (0.04%) 
Axillary vein thrombosis * 1  1/2264 (0.04%) 
Haemodynamic instability * 1  1/2264 (0.04%) 
Thrombophlebitis superficial * 1  1/2264 (0.04%) 
Vena cava thrombosis * 1  1/2264 (0.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab
Affected / at Risk (%)
Total   2095/2264 (92.54%) 
Eye disorders   
Lacrimation increased * 1  212/2264 (9.36%) 
Gastrointestinal disorders   
Stomatitis * 1  657/2264 (29.02%) 
Nausea * 1  667/2264 (29.46%) 
Diarrhoea * 1  613/2264 (27.08%) 
Constipation * 1  415/2264 (18.33%) 
Vomiting * 1  352/2264 (15.55%) 
Abdominal pain * 1  210/2264 (9.28%) 
Abdominal pain upper * 1  153/2264 (6.76%) 
Gingival bleeding * 1  131/2264 (5.79%) 
Dyspepsia * 1  119/2264 (5.26%) 
General disorders   
Fatigue * 1  1111/2264 (49.07%) 
Pyrexia * 1  361/2264 (15.95%) 
Oedema peripheral * 1  202/2264 (8.92%) 
Infections and infestations   
Urinary tract infection * 1  142/2264 (6.27%) 
Nasopharyngitis * 1  124/2264 (5.48%) 
Investigations   
Neutrophil count decreased * 1  587/2264 (25.93%) 
White blood cell count decreased * 1  566/2264 (25.00%) 
Haemoglobin decreased * 1  416/2264 (18.37%) 
Alanine aminotransferase increased * 1  293/2264 (12.94%) 
Aspartate aminotransferase increased * 1  259/2264 (11.44%) 
Blood alkaline phosphatase increased * 1  202/2264 (8.92%) 
Gamma-glutamyltransferase increased * 1  184/2264 (8.13%) 
Platelet count decreased * 1  166/2264 (7.33%) 
Blood lactate dehydrogenase increased * 1  114/2264 (5.04%) 
Metabolism and nutrition disorders   
Anorexia * 1  423/2264 (18.68%) 
Hyperglycaemia * 1  144/2264 (6.36%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  339/2264 (14.97%) 
Back pain * 1  305/2264 (13.47%) 
Myalgia * 1  270/2264 (11.93%) 
Pain in extremity * 1  277/2264 (12.23%) 
Bone pain * 1  247/2264 (10.91%) 
Musculoskeletal pain * 1  198/2264 (8.75%) 
Nervous system disorders   
Neuropathy * 1  446/2264 (19.70%) 
Headache * 1  409/2264 (18.07%) 
Dysgeusia * 1  168/2264 (7.42%) 
Neuropathy peripheral * 1  165/2264 (7.29%) 
Paraesthesia * 1  158/2264 (6.98%) 
Dizziness * 1  120/2264 (5.30%) 
Psychiatric disorders   
Insomnia * 1  136/2264 (6.01%) 
Renal and urinary disorders   
Proteinuria * 1  618/2264 (27.30%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  867/2264 (38.30%) 
Cough * 1  338/2264 (14.93%) 
Dyspnoea * 1  312/2264 (13.78%) 
Dysphonia * 1  149/2264 (6.58%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  934/2264 (41.25%) 
Nail disorder * 1  272/2264 (12.01%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  234/2264 (10.34%) 
Rash * 1  207/2264 (9.14%) 
Vascular disorders   
Hypertension * 1  760/2264 (33.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448591     History of Changes
Other Study ID Numbers: MO19391
First Submitted: March 16, 2007
First Posted: March 19, 2007
Results First Submitted: December 22, 2014
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015