Trial Outcomes & Findings for A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L) (NCT NCT00434226)
NCT ID: NCT00434226
Last Updated: 2009-08-21
Results Overview
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
TERMINATED
PHASE2
56 participants
From randomization until disease progression/recurrence
2009-08-21
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
26
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)
Baseline characteristics by cohort
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=30 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
n=26 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Age, Customized
<18 Years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 64 Years
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
>=65 Years
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression/recurrencePopulation: Randomized patients with at least one scan available at baseline and post-baseline
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Outcome measures
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=25 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
n=19 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Best Response
Complete Response
|
0 participants
|
0 participants
|
|
Best Response
Partial Response
|
12 participants
|
9 participants
|
|
Best Response
Stable Disease
|
10 participants
|
9 participants
|
|
Best Response
Progressive Disease
|
2 participants
|
1 participants
|
|
Best Response
Unable to Evaluate
|
0 participants
|
0 participants
|
|
Best Response
Missing
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 60 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=29 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
n=26 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Serious Adverse Events
Anaemia
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Febrile Neutropenia
|
4 participants
|
1 participants
|
|
Serious Adverse Events
Neutropenia
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Thrombocytopenia
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Cardiac Arrest
|
1 participants
|
1 participants
|
|
Serious Adverse Events
Diarrhoea
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Asthenia
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Disease Progression
|
1 participants
|
1 participants
|
|
Serious Adverse Events
Fatigue
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Pain
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Hepatic Pain
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Drug Hypersensitivity
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Cellulitis
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Bacterial Sepsis
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Collapse of Lung
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Platelet Count Decreased
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Haemoglobin Decreased
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Nutrophil Count Decreased
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Dehydration
|
2 participants
|
1 participants
|
|
Serious Adverse Events
Back Pain
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Lung Cancer Metastatic
|
0 participants
|
2 participants
|
|
Serious Adverse Events
Gastric Cancer
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Non-Small Cell Lung Cancer
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Confusional State
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Renal Failure
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Pleural Effusion
|
0 participants
|
2 participants
|
|
Serious Adverse Events
Pneumothorax
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Chronic Obstructive Pulmonary Disease
|
0 participants
|
2 participants
|
|
Serious Adverse Events
Pulmonary Embolism
|
2 participants
|
0 participants
|
|
Serious Adverse Events
Dyspnoea
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Haemoptysis
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Pneumonitis
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Pulmonary Haemorrhage
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Nasal Septum Perforation
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Aortic Aneurysm
|
1 participants
|
0 participants
|
|
Serious Adverse Events
Hypotension
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 60 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=29 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
n=26 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Incidence of Grade ≥ 3 Adverse Events
Anaemia
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Febrile Nutropenia
|
4 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Leukopenia
|
6 participants
|
3 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Neutropenia
|
18 participants
|
12 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Thrombocytopenia
|
7 participants
|
5 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Cardiac Arrest
|
1 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Left Ventricular Dysfunction
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Diarrhoea
|
1 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Gastrointestinal Haemorrhage
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Asthenia
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Disease Progression
|
1 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Fatigue
|
2 participants
|
3 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pain
|
1 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hepatic Pain
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Drug Hypersensitivity
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hypersensitivity
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Bacterial Sepsis
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Cellulitis
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Infection
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pneumonia
|
0 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Collapse of Lung
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Aspartate Aminotransferase Increased
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Blood Alkaline Phosphatase Increased
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Fibrin D Dimer Increased
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Haemoglobin Decreased
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
International Normalised Ratio Increased
|
1 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Nutrophil Count Decreased
|
1 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Platelet Count Decreased
|
4 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
White Blood Cell Count Decreased
|
2 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Anorexia
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Dehydration
|
2 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hyperglycaemia
|
0 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hypoalbuminaemia
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hypocalcaemia
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hyponatraemia
|
0 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Arthralgia
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Back Pain
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Muscular Weakness
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Musculoskeletal Pain
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Gastric Cancer
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Lung Cancer Metastatic
|
0 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Metastases to Central Nervous System
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Non-Small Cell Lung Cancer
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Dizziness
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Confusional State
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Albuminuria
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Renal Failure
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Chronic Obstructive Pulmonary Disease
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Dyspnoea
|
2 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pleural Effusion
|
0 participants
|
2 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pneumonitis
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pulmonary Embolism
|
2 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Pulmonary Haemorrhage
|
0 participants
|
1 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Leukocytoclastic Vasculitis
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Rash
|
2 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Aortic Aneurysm
|
1 participants
|
0 participants
|
|
Incidence of Grade ≥ 3 Adverse Events
Hypertension
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 60 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=29 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Anaemia
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Febrile Nutropenia
|
2 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Leukopenia
|
4 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Neutropenia
|
11 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Thrombocytopenia
|
6 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Left Ventricular Dysfunction
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Diarrhoea
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Gastrointestinal Haemorrhage
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Nausea
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Stomatitis
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Disease Progression
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Fatigue
|
2 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Bronchitis
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Cellulitis
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Infection
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Collapse of Lung
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Aspartate Aminotransferase Increased
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Fibrin D Dimer Increased
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
International Normalised Ratio Increased
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Neutrophil Count Decreased
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Platelet Count Decreased
|
5 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
White Blood Cell Count Decreased
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Anorexia
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Dehydration
|
2 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Hypoalbuminaemia
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Back Pain
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Muscular Weakness
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Musculoskeletal Pain
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Gastric Cancer
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Metastases to Central Nervous System
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Non-Small Cell Lung Cancer
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Dizziness
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Albuminuria
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Pnemothorax
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Dyspnoea
|
2 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Pulmonary Embolism
|
2 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Leukocytoclastic Vasculitis
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Rash
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Aortic Aneurysm
|
1 participants
|
—
|
|
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Hypertension
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: 60 days following the last administration of study treatmentPopulation: Treated patients
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Outcome measures
| Measure |
Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
n=29 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
|
Bevacizumab + Carboplatin/Paclitaxel
n=26 Participants
Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
|
|---|---|---|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Anaemia
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Febrile Nutropenia
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Leukopenia
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Neutropenia
|
3 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Thrombocytopenia
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Cardiac Arrest
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Diarrhoea
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Gastrointestinal Haemorrhage
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Disease Progression
|
1 participants
|
2 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Fatigue
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Drug Hypersensitivity
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hypersensitivity
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Bronchitis
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Infection
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Collapse of Lung
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Aspartate Aminotransferase Increased
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
International Normalised Ratio Increased
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Neutrophil Count Decreased
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Platelet Count Decreased
|
5 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Dehydration
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Back Pain
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Gastric Cancer
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Lung Cancer Metastatic
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Metastases to Central Nervous System
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Metastases to Liver
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Non-Small Cell Lung Cancer
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Albuminuria
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Renal Failure
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Haemoptysis
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Pleural Effusion
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Pneumothorax
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Pulmonary Embolism
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Rash
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Aortic Aneurysm
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hypertension
|
2 participants
|
2 participants
|
|
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Hypotension
|
0 participants
|
1 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Medical Communications Specialist
Genentech, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER