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A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01077713
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Squamous Non-Small Cell Lung Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: cisplatin
Drug: gemcitabine
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Period Title: Overall Study
Started 44 42
Completed 8 6
Not Completed 36 36
Reason Not Completed
Withdrawal by Subject             1             2
Progressive Disease (PD)             0             1
Death             28             29
Lost to Follow-up             1             1
Adverse Event             2             1
Other             4             2
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin Total
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 44 42 86
Hide Baseline Analysis Population Description
All participants randomized set (RND) included all participants who provided informed consent and who were randomized to study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 42 participants 86 participants
74.2  (3.2) 73.8  (3.5) 74.0  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 86 participants
Female
16
  36.4%
12
  28.6%
28
  32.6%
Male
28
  63.6%
30
  71.4%
58
  67.4%
1.Primary Outcome
Title Percentage of Participants Alive and Without Progressive Disease at Month 6
Hide Description Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
Time Frame Month 6
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Hide Analysis Population Description
Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.6
(12.5 to 38.6)
30.0
(15.8 to 44.2)
2.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death
Hide Description Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time Frame Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Unit of Measure: percentage of participants
86.0 90.0
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Time Frame Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: months
4.33
(2.20 to 5.97)
6.82
(4.49 to 8.52)
4.Secondary Outcome
Title Percentage of Participants Alive at 12 Months After Randomization
Hide Description [Not Specified]
Time Frame 1 year
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.2
(22.8 to 51.7)
47.5
(32.0 to 63.0)
5.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description [Not Specified]
Time Frame From randomization to death or end of the study (up to 53 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Unit of Measure: percentage of participants
69.8 72.5
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
Time Frame From randomization to death or end of the study (up to 53 months)
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: months
5.66
(3.38 to 13.0)
12.0
(9.93 to 19.6)
7.Secondary Outcome
Title Percentage of Participants by Best Overall Response
Hide Description Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
PR
14.0
(3.6 to 24.3)
35.0
(20.2 to 49.8)
SD
39.5
(24.9 to 54.1)
37.5
(22.5 to 52.5)
PD
16.3
(5.2 to 27.3)
12.5
(2.2 to 22.7)
Not Assessable
30.2
(16.5 to 44.0)
15.0
(3.9 to 26.1)
8.Secondary Outcome
Title Percentage of Participants With an Objective Response
Hide Description Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.
Time Frame Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
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ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cycle 3
11.6
(2.05 to 21.2)
27.5
(13.7 to 41.3)
Cycle 6
9.3
(0.62 to 18.0)
15.0
(3.93 to 26.1)
Month 6
4.7
(0.00 to 10.9)
10.0
(0.70 to 19.3)
9.Secondary Outcome
Title Percentage of Participants With Disease Control
Hide Description Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time Frame Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6
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Hide Analysis Population Description
ITT set
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cycle 3
53.5
(38.6 to 68.4)
67.5
(53.0 to 82.0)
Cycle 6
27.9
(14.5 to 41.3)
37.5
(22.5 to 52.5)
Month 6
25.6
(12.5 to 38.6)
30.0
(15.8 to 44.2)
10.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.
Time Frame Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)
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ITT set.
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
Overall Number of Participants Analyzed 43 40
Median (95% Confidence Interval)
Unit of Measure: months
5.23 [1] 
(3.93 to NA)
5.97
(2.20 to 9.08)
[1]
It was not possible to estimate the statistic using Kaplan-Meier because upper bound of 95% confidence interval was not reached.
Time Frame From baseline to 28 days after last dose of any study drug (up to 54 months)
Adverse Event Reporting Description Safety set included all participants in the RND set who received at least one dose of any study medication. Participants were classified according to treatment received.
 
Arm/Group Title Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity. Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
All-Cause Mortality
Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   17/43 (39.53%)   10/40 (25.00%) 
Cardiac disorders     
Atrial fibrillation * 1  0/43 (0.00%)  1/40 (2.50%) 
Cardiac arrest * 1  1/43 (2.33%)  0/40 (0.00%) 
Cardiac failure * 1  1/43 (2.33%)  0/40 (0.00%) 
Myocardial infarction * 1  0/43 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Nausea * 1  0/43 (0.00%)  1/40 (2.50%) 
General disorders     
General physical health deterioration * 1  2/43 (4.65%)  0/40 (0.00%) 
Pyrexia * 1  1/43 (2.33%)  0/40 (0.00%) 
Infections and infestations     
Bronchopneumonia * 1  1/43 (2.33%)  0/40 (0.00%) 
Pneumonia * 1  0/43 (0.00%)  1/40 (2.50%) 
Urinary tract infection * 1  1/43 (2.33%)  0/40 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/43 (0.00%)  1/40 (2.50%) 
Overdose * 1  1/43 (2.33%)  0/40 (0.00%) 
Nervous system disorders     
Aphasia * 1  1/43 (2.33%)  0/40 (0.00%) 
Dizziness * 1  0/43 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/43 (2.33%)  0/40 (0.00%) 
Dyspnoea * 1  2/43 (4.65%)  0/40 (0.00%) 
Haemoptysis * 1  2/43 (4.65%)  0/40 (0.00%) 
Lung disease * 1  1/43 (2.33%)  0/40 (0.00%) 
Pneumonitis * 1  1/43 (2.33%)  0/40 (0.00%) 
Pulmonary Haemorrhage * 1  0/43 (0.00%)  1/40 (2.50%) 
Pulmonary oedema * 1  0/43 (0.00%)  1/40 (2.50%) 
Respiratory failure * 1  2/43 (4.65%)  0/40 (0.00%) 
Surgical and medical procedures     
Hospitalisation * 1  1/43 (2.33%)  0/40 (0.00%) 
Vascular disorders     
Embolism * 1  1/43 (2.33%)  2/40 (5.00%) 
Hypertension * 1  0/43 (0.00%)  1/40 (2.50%) 
Thrombosis * 1  0/43 (0.00%)  1/40 (2.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Gemcitabine Bevacizumab + Gemcitabine + Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   38/43 (88.37%)   37/40 (92.50%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/43 (11.63%)  12/40 (30.00%) 
Leukopenia * 1  0/43 (0.00%)  11/40 (27.50%) 
Neutropenia * 1  12/43 (27.91%)  23/40 (57.50%) 
Thrombocytopenia * 1  5/43 (11.63%)  16/40 (40.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/43 (0.00%)  2/40 (5.00%) 
Abdominal pain upper * 1  0/43 (0.00%)  2/40 (5.00%) 
Constipation * 1  3/43 (6.98%)  8/40 (20.00%) 
Diarrhoea * 1  3/43 (6.98%)  5/40 (12.50%) 
Nausea * 1  8/43 (18.60%)  17/40 (42.50%) 
Vomiting * 1  5/43 (11.63%)  6/40 (15.00%) 
General disorders     
Asthenia * 1  9/43 (20.93%)  10/40 (25.00%) 
Chest pain * 1  4/43 (9.30%)  2/40 (5.00%) 
Fatigue * 1  8/43 (18.60%)  15/40 (37.50%) 
Mucosal inflammation * 1  0/43 (0.00%)  5/40 (12.50%) 
Pain * 1  0/43 (0.00%)  2/40 (5.00%) 
Pyrexia * 1  8/43 (18.60%)  8/40 (20.00%) 
Infections and infestations     
Tooth abscess * 1  0/43 (0.00%)  2/40 (5.00%) 
Investigations     
Blood creatinine increased * 1  0/43 (0.00%)  4/40 (10.00%) 
Platelet count decreased * 1  4/43 (9.30%)  5/40 (12.50%) 
Metabolism and nutrition disorders     
Hyperkalaemia * 1  0/43 (0.00%)  2/40 (5.00%) 
Hypocalcaemia * 1  0/43 (0.00%)  3/40 (7.50%) 
Hyponatraemia * 1  0/43 (0.00%)  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/43 (0.00%)  3/40 (7.50%) 
Bone pain * 1  5/43 (11.63%)  4/40 (10.00%) 
Pain in extremity * 1  3/43 (6.98%)  0/40 (0.00%) 
Nervous system disorders     
Dizziness * 1  3/43 (6.98%)  8/40 (20.00%) 
Paraesthesia * 1  0/43 (0.00%)  2/40 (5.00%) 
Renal and urinary disorders     
Proteinuria * 1  5/43 (11.63%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  4/43 (9.30%)  6/40 (15.00%) 
Dyspnoea * 1  4/43 (9.30%)  7/40 (17.50%) 
Epistaxis * 1  0/43 (0.00%)  2/40 (5.00%) 
Haemoptysis * 1  5/43 (11.63%)  4/40 (10.00%) 
Productive cough * 1  0/43 (0.00%)  3/40 (7.50%) 
Vascular disorders     
Embolism * 1  0/43 (0.00%)  5/40 (12.50%) 
Hypertension * 1  11/43 (25.58%)  9/40 (22.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01077713    
Other Study ID Numbers: ML21868
2008-008739-27
First Submitted: February 9, 2010
First Posted: March 1, 2010
Results First Submitted: September 9, 2015
Results First Posted: October 8, 2015
Last Update Posted: October 8, 2015