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Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01966003
Recruitment Status : Completed
First Posted : October 21, 2013
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Actavis Inc.
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer Metastatic
Interventions Drug: Carboplatin
Drug: Paclitaxel
Drug: ABP 215
Drug: Bevacizumab
Enrollment 642
Recruitment Details This study was conducted at 101 sites (14 sites in the US, 11 in Russia, 10 in Australia, 9 in Germany, 8 in Poland, 7 in Hungary, 7 in Romania, 6 in Italy, 6 in Spain, 5 in Bulgaria, 5 in Greece, 3 in the Czech Republic, 3 in Mexico, 3 in Taiwan, 2 in the Netherlands, 1 in Canada, and 1 in Hong Kong).
Pre-assignment Details Eligible participants were randomized in a 1:1 ratio to receive ABP 215 or bevacizumab. Participants were stratified by geographic region (Eastern Europe vs Western Europe vs Asia Pacific/Other vs North America), Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1), and sex.
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Period Title: Overall Study
Started 328 314
Received Study Drug 324 309
Completed 58 44
Not Completed 270 270
Reason Not Completed
Death             43             36
Protocol Violation             6             4
Lost to Follow-up             4             3
Physician Decision             12             13
Withdrawal by Subject             29             19
Plan to Receive Other Anticancer Therapy             131             127
Plan to Receive Commercial Bevacizumab             44             67
Other             1             1
Arm/Group Title ABP 215 Bevacizumab Total
Hide Arm/Group Description Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. Total of all reporting groups
Overall Number of Baseline Participants 328 314 642
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 328 participants 314 participants 642 participants
61.6  (9.09) 61.6  (8.88) 61.6  (8.98)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
< 65 years 199 191 390
≥ 65 years 129 123 252
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
Female
132
  40.2%
126
  40.1%
258
  40.2%
Male
196
  59.8%
188
  59.9%
384
  59.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
Hispanic or Latino
14
   4.3%
16
   5.1%
30
   4.7%
Not Hispanic or Latino
314
  95.7%
298
  94.9%
612
  95.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
White 315 300 615
Black or African American 2 5 7
Asian 6 7 13
American Indian or Alaska Native 2 0 2
Native Hawaiian or other Pacific Islander 1 0 1
Other 4 2 6
[1]
Measure Description: Participants were allowed to choose multiple races.
Geographic Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
Eastern Europe 189 186 375
Western Europe 78 76 154
North America 31 26 57
Asia Pacific/Other 30 26 56
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 328 participants 314 participants 642 participants
Grade 0 127 117 244
Grade 1 201 197 398
[1]
Measure Description: A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
1.Primary Outcome
Title Percentage of Participants With an Objective Response
Hide Description

Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.

CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.

PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.

Time Frame Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population which consisted of all randomized participants.
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 328 314
Measure Type: Number
Unit of Measure: percentage of participants
39.0 41.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 215, Bevacizumab
Comments The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
0.80 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 215, Bevacizumab
Comments Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.90
Confidence Interval (2-Sided) 90%
-9.26 to 3.45
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Duration of Response
Hide Description

Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists’ review.

DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.

Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.

Time Frame Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with an objective response
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 128 131
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(4.9 to 7.7)
5.6
(5.1 to 6.3)
3.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists’ review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.

Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions.

Time Frame From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 328 314
Median (95% Confidence Interval)
Unit of Measure: months
6.6
(6.3 to 7.9)
7.9
(6.6 to 8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 215, Bevacizumab
Comments The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.83 to 1.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.

A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:

  • fatal
  • life-threatening
  • required inpatient hospitalization or prolongation of existing hospitalization
  • resulted in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event
Time Frame up to 19 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population consisted of all participants who received any amount of study drug.
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 324 309
Measure Type: Number
Unit of Measure: participants
Any adverse event 308 289
Any grade ≥ 3 adverse event 139 137
Any fatal adverse event 13 11
Any serious adverse event 85 71
Any AE leading to discontinuation of study drug 61 53
Any AE leading to discontinuation of chemotherapy 74 59
Any AE leading to dose delay of study drug 73 69
Any AE leading to dose delay of any chemotherapy 86 83
Any AE leading to dose reduction of chemotherapy 48 49
5.Secondary Outcome
Title Number of Participants Who Developed Anti-drug Antibodies
Hide Description Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Time Frame 44 weeks (6 months after end of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population with available data
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 294 284
Measure Type: Number
Unit of Measure: participants
Binding antibody positive 4 7
Neutralizing antibody positive 0 0
6.Secondary Outcome
Title Overall Survival
Hide Description

Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.

Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment).

Time Frame From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description:
Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Overall Number of Participants Analyzed 324 309
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(14.6 to NA)
[1]
Could not be estimated due to the low number of deaths
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 215, Bevacizumab
Comments Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 90%
0.75 to 1.61
Estimation Comments [Not Specified]
Time Frame 19 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title ABP 215 Bevacizumab
Hide Arm/Group Description Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
All-Cause Mortality
ABP 215 Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABP 215 Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   85/324 (26.23%)   71/309 (22.98%) 
Blood and lymphatic system disorders     
Anaemia  1  3/324 (0.93%)  6/309 (1.94%) 
Febrile neutropenia  1  11/324 (3.40%)  8/309 (2.59%) 
Hypercoagulation  1  0/324 (0.00%)  1/309 (0.32%) 
Neutropenia  1  6/324 (1.85%)  3/309 (0.97%) 
Pancytopenia  1  0/324 (0.00%)  1/309 (0.32%) 
Thrombocytopenia  1  2/324 (0.62%)  2/309 (0.65%) 
Cardiac disorders     
Acute left ventricular failure  1  0/324 (0.00%)  1/309 (0.32%) 
Acute myocardial infarction  1  1/324 (0.31%)  0/309 (0.00%) 
Atrial fibrillation  1  1/324 (0.31%)  1/309 (0.32%) 
Cardiac arrest  1  1/324 (0.31%)  0/309 (0.00%) 
Cardiopulmonary failure  1  1/324 (0.31%)  0/309 (0.00%) 
Coronary artery disease  1  1/324 (0.31%)  0/309 (0.00%) 
Paroxysmal arrhythmia  1  0/324 (0.00%)  1/309 (0.32%) 
Pericardial effusion  1  1/324 (0.31%)  0/309 (0.00%) 
Ventricular extrasystoles  1  1/324 (0.31%)  0/309 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/324 (0.00%)  1/309 (0.32%) 
Gastrointestinal disorders     
Abdominal pain  1  1/324 (0.31%)  0/309 (0.00%) 
Anal haemorrhage  1  1/324 (0.31%)  0/309 (0.00%) 
Constipation  1  1/324 (0.31%)  0/309 (0.00%) 
Diarrhoea  1  3/324 (0.93%)  2/309 (0.65%) 
Diarrhoea haemorrhagic  1  1/324 (0.31%)  0/309 (0.00%) 
Diverticular perforation  1  0/324 (0.00%)  1/309 (0.32%) 
Faecaloma  1  0/324 (0.00%)  1/309 (0.32%) 
Gastrointestinal haemorrhage  1  1/324 (0.31%)  0/309 (0.00%) 
Intestinal perforation  1  1/324 (0.31%)  1/309 (0.32%) 
Large intestinal haemorrhage  1  1/324 (0.31%)  0/309 (0.00%) 
Large intestine perforation  1  1/324 (0.31%)  1/309 (0.32%) 
Melaena  1  1/324 (0.31%)  0/309 (0.00%) 
Mesenteric artery embolism  1  1/324 (0.31%)  0/309 (0.00%) 
Nausea  1  2/324 (0.62%)  1/309 (0.32%) 
Rectal haemorrhage  1  2/324 (0.62%)  0/309 (0.00%) 
Small intestinal obstruction  1  1/324 (0.31%)  0/309 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/324 (0.31%)  0/309 (0.00%) 
Vomiting  1  2/324 (0.62%)  1/309 (0.32%) 
General disorders     
Death  1  2/324 (0.62%)  1/309 (0.32%) 
Fatigue  1  2/324 (0.62%)  0/309 (0.00%) 
General physical health deterioration  1  2/324 (0.62%)  2/309 (0.65%) 
Non-cardiac chest pain  1  1/324 (0.31%)  0/309 (0.00%) 
Pyrexia  1  1/324 (0.31%)  2/309 (0.65%) 
Sudden death  1  0/324 (0.00%)  1/309 (0.32%) 
Hepatobiliary disorders     
Hepatitis  1  1/324 (0.31%)  0/309 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/324 (0.31%)  0/309 (0.00%) 
Infections and infestations     
Abscess soft tissue  1  0/324 (0.00%)  1/309 (0.32%) 
Anal abscess  1  0/324 (0.00%)  1/309 (0.32%) 
Appendicitis  1  1/324 (0.31%)  0/309 (0.00%) 
Bronchopneumonia  1  0/324 (0.00%)  1/309 (0.32%) 
Bronchopulmonary aspergillosis  1  1/324 (0.31%)  0/309 (0.00%) 
Cellulitis  1  1/324 (0.31%)  0/309 (0.00%) 
Cytomegalovirus hepatitis  1  0/324 (0.00%)  1/309 (0.32%) 
Empyema  1  0/324 (0.00%)  2/309 (0.65%) 
Escherichia bacteraemia  1  1/324 (0.31%)  0/309 (0.00%) 
Influenza  1  1/324 (0.31%)  0/309 (0.00%) 
Lower respiratory tract infection  1  1/324 (0.31%)  0/309 (0.00%) 
Lung infection  1  1/324 (0.31%)  1/309 (0.32%) 
Neutropenic infection  1  0/324 (0.00%)  1/309 (0.32%) 
Neutropenic sepsis  1  1/324 (0.31%)  0/309 (0.00%) 
Peritonitis  1  0/324 (0.00%)  2/309 (0.65%) 
Pilonidal cyst  1  0/324 (0.00%)  1/309 (0.32%) 
Pneumonia  1  6/324 (1.85%)  5/309 (1.62%) 
Pseudomonas infection  1  1/324 (0.31%)  0/309 (0.00%) 
Pulmonary sepsis  1  1/324 (0.31%)  0/309 (0.00%) 
Respiratory tract infection  1  2/324 (0.62%)  2/309 (0.65%) 
Sepsis  1  1/324 (0.31%)  1/309 (0.32%) 
Septic shock  1  1/324 (0.31%)  0/309 (0.00%) 
Urinary tract infection  1  0/324 (0.00%)  1/309 (0.32%) 
Injury, poisoning and procedural complications     
Brain contusion  1  1/324 (0.31%)  0/309 (0.00%) 
Femoral neck fracture  1  1/324 (0.31%)  0/309 (0.00%) 
Humerus fracture  1  1/324 (0.31%)  0/309 (0.00%) 
Infusion related reaction  1  0/324 (0.00%)  1/309 (0.32%) 
Lumbar vertebral fracture  1  1/324 (0.31%)  0/309 (0.00%) 
Road traffic accident  1  1/324 (0.31%)  0/309 (0.00%) 
Toxicity to various agents  1  1/324 (0.31%)  0/309 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/324 (0.31%)  0/309 (0.00%) 
Metabolism and nutrition disorders     
Cachexia  1  1/324 (0.31%)  0/309 (0.00%) 
Decreased appetite  1  0/324 (0.00%)  1/309 (0.32%) 
Dehydration  1  0/324 (0.00%)  2/309 (0.65%) 
Hyperglycaemia  1  1/324 (0.31%)  0/309 (0.00%) 
Hyponatraemia  1  1/324 (0.31%)  0/309 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/324 (0.00%)  1/309 (0.32%) 
Back pain  1  0/324 (0.00%)  1/309 (0.32%) 
Musculoskeletal chest pain  1  1/324 (0.31%)  1/309 (0.32%) 
Pathological fracture  1  1/324 (0.31%)  0/309 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to bone  1  1/324 (0.31%)  0/309 (0.00%) 
Tumour pain  1  0/324 (0.00%)  1/309 (0.32%) 
Nervous system disorders     
Brain oedema  1  0/324 (0.00%)  1/309 (0.32%) 
Cerebral ischaemia  1  2/324 (0.62%)  1/309 (0.32%) 
Depressed level of consciousness  1  1/324 (0.31%)  0/309 (0.00%) 
Dysarthria  1  1/324 (0.31%)  0/309 (0.00%) 
Encephalopathy  1  2/324 (0.62%)  0/309 (0.00%) 
Ischaemic cerebral infarction  1  1/324 (0.31%)  0/309 (0.00%) 
Ischaemic stroke  1  0/324 (0.00%)  1/309 (0.32%) 
Migraine  1  2/324 (0.62%)  0/309 (0.00%) 
Paraesthesia  1  1/324 (0.31%)  0/309 (0.00%) 
Seizure  1  0/324 (0.00%)  1/309 (0.32%) 
Spinal cord compression  1  0/324 (0.00%)  1/309 (0.32%) 
Syncope  1  0/324 (0.00%)  1/309 (0.32%) 
Transient ischaemic attack  1  2/324 (0.62%)  1/309 (0.32%) 
Psychiatric disorders     
Hallucinations, mixed  1  1/324 (0.31%)  0/309 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  0/324 (0.00%)  1/309 (0.32%) 
Renal failure  1  1/324 (0.31%)  0/309 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial fistula  1  1/324 (0.31%)  1/309 (0.32%) 
Chronic obstructive pulmonary disease  1  1/324 (0.31%)  1/309 (0.32%) 
Dyspnoea  1  3/324 (0.93%)  4/309 (1.29%) 
Epistaxis  1  2/324 (0.62%)  0/309 (0.00%) 
Haemoptysis  1  3/324 (0.93%)  5/309 (1.62%) 
Pleural effusion  1  1/324 (0.31%)  0/309 (0.00%) 
Pneumothorax  1  2/324 (0.62%)  1/309 (0.32%) 
Pulmonary artery thrombosis  1  0/324 (0.00%)  1/309 (0.32%) 
Pulmonary embolism  1  5/324 (1.54%)  6/309 (1.94%) 
Pulmonary haemorrhage  1  0/324 (0.00%)  1/309 (0.32%) 
Respiratory distress  1  1/324 (0.31%)  0/309 (0.00%) 
Respiratory failure  1  2/324 (0.62%)  1/309 (0.32%) 
Skin and subcutaneous tissue disorders     
Rash generalised  1  1/324 (0.31%)  0/309 (0.00%) 
Subcutaneous emphysema  1  0/324 (0.00%)  1/309 (0.32%) 
Surgical and medical procedures     
Prophylaxis  1  1/324 (0.31%)  0/309 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/324 (0.31%)  1/309 (0.32%) 
Embolism arterial  1  1/324 (0.31%)  1/309 (0.32%) 
Haematoma  1  0/324 (0.00%)  1/309 (0.32%) 
Hypotension  1  0/324 (0.00%)  1/309 (0.32%) 
Thrombosis  1  1/324 (0.31%)  0/309 (0.00%) 
Venous thrombosis  1  1/324 (0.31%)  1/309 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABP 215 Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   286/324 (88.27%)   276/309 (89.32%) 
Blood and lymphatic system disorders     
Anaemia  1  65/324 (20.06%)  60/309 (19.42%) 
Leukopenia  1  23/324 (7.10%)  23/309 (7.44%) 
Neutropenia  1  55/324 (16.98%)  60/309 (19.42%) 
Thrombocytopenia  1  47/324 (14.51%)  43/309 (13.92%) 
Gastrointestinal disorders     
Constipation  1  36/324 (11.11%)  36/309 (11.65%) 
Diarrhoea  1  39/324 (12.04%)  55/309 (17.80%) 
Gingival bleeding  1  9/324 (2.78%)  19/309 (6.15%) 
Nausea  1  82/324 (25.31%)  95/309 (30.74%) 
Stomatitis  1  15/324 (4.63%)  18/309 (5.83%) 
Vomiting  1  37/324 (11.42%)  41/309 (13.27%) 
General disorders     
Asthenia  1  49/324 (15.12%)  42/309 (13.59%) 
Fatigue  1  57/324 (17.59%)  59/309 (19.09%) 
Pyrexia  1  19/324 (5.86%)  20/309 (6.47%) 
Investigations     
Weight decreased  1  18/324 (5.56%)  16/309 (5.18%) 
Metabolism and nutrition disorders     
Decreased appetite  1  54/324 (16.67%)  42/309 (13.59%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  23/324 (7.10%)  29/309 (9.39%) 
Back pain  1  14/324 (4.32%)  19/309 (6.15%) 
Bone pain  1  20/324 (6.17%)  25/309 (8.09%) 
Myalgia  1  39/324 (12.04%)  44/309 (14.24%) 
Pain in extremity  1  24/324 (7.41%)  20/309 (6.47%) 
Nervous system disorders     
Dizziness  1  13/324 (4.01%)  25/309 (8.09%) 
Headache  1  28/324 (8.64%)  24/309 (7.77%) 
Neuropathy peripheral  1  56/324 (17.28%)  38/309 (12.30%) 
Paraesthesia  1  28/324 (8.64%)  40/309 (12.94%) 
Peripheral sensory neuropathy  1  18/324 (5.56%)  16/309 (5.18%) 
Polyneuropathy  1  20/324 (6.17%)  22/309 (7.12%) 
Renal and urinary disorders     
Proteinuria  1  26/324 (8.02%)  19/309 (6.15%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  26/324 (8.02%)  21/309 (6.80%) 
Dyspnoea  1  24/324 (7.41%)  24/309 (7.77%) 
Epistaxis  1  44/324 (13.58%)  39/309 (12.62%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  140/324 (43.21%)  127/309 (41.10%) 
Vascular disorders     
Hypertension  1  51/324 (15.74%)  41/309 (13.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01966003     History of Changes
Other Study ID Numbers: 20120265
2013-000738-36 ( EudraCT Number )
First Submitted: October 4, 2013
First Posted: October 21, 2013
Results First Submitted: September 21, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017