Non-Small Cell Lung Cancer
Conditions
Keywords
SABER-L, NSCLC, Avastin, Sutent
Brief summary
This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).
Interventions
DRUGbevacizumab
Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
DRUGsunitinib
25 mg/day for 2 weeks, followed by 1 week of rest
DRUGcarboplatin
On the first day of each cycle for 4 cycles
DRUGpaclitaxel
On the first day of each cycle for 4 cycles
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Age ≥ 18 years * Advanced histologically or cytologically confirmed NSCLC (Stage IIIb with malignant pleural or pericardial effusion, Stage IV, or recurrent) * Measurable or non-measurable disease * Patients with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period (brain imaging to be competed Day -7 to Day 1). * Prior treatment for CNS disease as deemed appropriate by the treating physician * ECOG performance status 0 or 1 * Ability and willingness to comply with study and follow-up procedures
Exclusion criteria
* Prior systemic chemotherapy for metastatic disease * Active malignancy other than lung cancer * Current, recent, or planned participation in another experimental drug study * Prior treatment with anti-VEGF agent or agents targeting similar pathways as sunitinib * Adjuvant chemotherapy or prior combined modality neoadjuvant therapy (chemotherapy plus radiotherapy with or without surgery) within 6 months prior to Day 1 of Cycle 1 * Life expectancy of \< 12 weeks * Current, recent, or planned participation in an experimental drug study * Inability to take oral medication or requirement of IV alimentation or total parenteral nutrition, or prior surgical procedures affecting absorption * Inadequate organ function * Known evidence of disseminated intravascular coagulopathy * Active infection or fever \> 38.5°C within 3 days prior to Day 1 of Cycle 1 * Untreated abnormal thyroid function tests as defined by institutional standards (patients with controlled hypothyroidism are eligible for study participation) * Any other medical condition(s) (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results * Intrathoracic lung carcinoma of squamous cell histology * Known CNS disease except for treated brain metastases * Inadequately controlled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Class II or greater CHF * History of myocardial infarction or unstable angina within 12 months prior to Day 1 of Cycle 1 * History of stroke or transient ischemic attack within 12 months prior to Day 1 of Cycle 1 * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1 of Cycle 1 * History of hemoptysis within 1 month prior to Day 1 of Cycle 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of Cycle 1 * History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of Cycle 1 * Serious, non-healing wound, active ulcer, or untreated bone fracture * Proteinuria at screening, as demonstrated by a urine protein/creatinine ratio of ≥ 1.0 at screening * Known hypersensitivity to any component of bevacizumab or sunitinib * Pregnancy (positive pregnancy test) or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Response | From randomization until disease progression/recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | 60 days following the last administration of study treatment | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0 |
| Incidence of Grade ≥ 3 Adverse Events | 60 days following the last administration of study treatment | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0 |
| Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | 60 days following the last administration of study treatment | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0 |
| Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | 60 days following the last administration of study treatment | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 26 |
| Total | 56 |
Baseline characteristics
| Characteristic | Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Bevacizumab + Carboplatin/Paclitaxel | Total |
|---|---|---|---|
| Age Continuous | 63.7 years STANDARD_DEVIATION 9.5 | 64.8 years STANDARD_DEVIATION 10.7 | 64.2 years STANDARD_DEVIATION 10 |
| Age, Customized <18 Years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 Years | 15 participants | 13 participants | 28 participants |
| Age, Customized Between 18 and 64 Years | 15 participants | 13 participants | 28 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Outcome results
Primary
Best Response
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.
Time frame: From randomization until disease progression/recurrence
Population: Randomized patients with at least one scan available at baseline and post-baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Progressive Disease | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Partial Response | 12 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Unable to Evaluate | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Complete Response | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Missing | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Best Response | Stable Disease | 10 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Missing | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Stable Disease | 9 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Progressive Disease | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Complete Response | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Partial Response | 9 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Best Response | Unable to Evaluate | 0 participants |
Secondary
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Population: Treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Gastric Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Lung Cancer Metastatic | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Infection | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Metastases to Central Nervous System | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Neutropenia | 3 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Metastases to Liver | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Collapse of Lung | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Non-Small Cell Lung Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Fatigue | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Albuminuria | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Aspartate Aminotransferase Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Renal Failure | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Leukopenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Haemoptysis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | International Normalised Ratio Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Rash | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Drug Hypersensitivity | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Aortic Aneurysm | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Neutrophil Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypertension | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Thrombocytopenia | 3 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypotension | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Platelet Count Decreased | 5 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypersensitivity | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Cardiac Arrest | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Anaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Diarrhoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Dehydration | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Gastrointestinal Haemorrhage | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Febrile Nutropenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pleural Effusion | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Back Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pneumothorax | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Bronchitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pulmonary Embolism | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Cardiac Arrest | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Anaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Febrile Nutropenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Leukopenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Neutropenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Gastrointestinal Haemorrhage | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Disease Progression | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Fatigue | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Drug Hypersensitivity | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypersensitivity | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Bronchitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Infection | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Collapse of Lung | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Aspartate Aminotransferase Increased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | International Normalised Ratio Increased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Neutrophil Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Platelet Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Dehydration | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Back Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Gastric Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Lung Cancer Metastatic | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Metastases to Central Nervous System | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Metastases to Liver | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Non-Small Cell Lung Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Albuminuria | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Renal Failure | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pulmonary Embolism | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Rash | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Aortic Aneurysm | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypertension | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Hypotension | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Thrombocytopenia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Diarrhoea | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Haemoptysis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pleural Effusion | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption | Pneumothorax | 0 participants |
Secondary
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Population: Treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Anaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Febrile Nutropenia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Leukopenia | 4 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Neutropenia | 11 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Thrombocytopenia | 6 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Left Ventricular Dysfunction | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Diarrhoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Gastrointestinal Haemorrhage | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Nausea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Stomatitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Fatigue | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Bronchitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Cellulitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Infection | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Collapse of Lung | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Aspartate Aminotransferase Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Fibrin D Dimer Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | International Normalised Ratio Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Neutrophil Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Platelet Count Decreased | 5 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | White Blood Cell Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Anorexia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Dehydration | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Hypoalbuminaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Back Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Muscular Weakness | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Musculoskeletal Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Gastric Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Metastases to Central Nervous System | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Non-Small Cell Lung Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Dizziness | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Albuminuria | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Pnemothorax | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Dyspnoea | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Pulmonary Embolism | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Leukocytoclastic Vasculitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Rash | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Aortic Aneurysm | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction | Hypertension | 3 participants |
Secondary
Incidence of Grade ≥ 3 Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Population: Treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Asthenia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Left Ventricular Dysfunction | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Diarrhoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Gastrointestinal Haemorrhage | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Musculoskeletal Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Lung Cancer Metastatic | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Metastases to Central Nervous System | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Non-Small Cell Lung Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Dizziness | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Cellulitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Infection | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pneumonia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Collapse of Lung | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Anaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Febrile Nutropenia | 4 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Leukopenia | 6 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Neutropenia | 18 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Bacterial Sepsis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Thrombocytopenia | 7 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Cardiac Arrest | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Fatigue | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hepatic Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Drug Hypersensitivity | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hypersensitivity | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Aspartate Aminotransferase Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Blood Alkaline Phosphatase Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Fibrin D Dimer Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Haemoglobin Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | International Normalised Ratio Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Nutrophil Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Platelet Count Decreased | 4 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | White Blood Cell Count Decreased | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Anorexia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Dehydration | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hyperglycaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hypoalbuminaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hypocalcaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hyponatraemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Arthralgia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Back Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Muscular Weakness | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Gastric Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Confusional State | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Albuminuria | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Renal Failure | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Chronic Obstructive Pulmonary Disease | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Dyspnoea | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pleural Effusion | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pneumonitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pulmonary Embolism | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Pulmonary Haemorrhage | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Leukocytoclastic Vasculitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Rash | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Aortic Aneurysm | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Incidence of Grade ≥ 3 Adverse Events | Hypertension | 3 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Gastric Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Cardiac Arrest | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Haemoglobin Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Left Ventricular Dysfunction | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Dizziness | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Diarrhoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | International Normalised Ratio Increased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Gastrointestinal Haemorrhage | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Asthenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Muscular Weakness | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pneumonitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Nutrophil Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Lung Cancer Metastatic | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Confusional State | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Metastases to Central Nervous System | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Platelet Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Non-Small Cell Lung Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Aortic Aneurysm | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Bacterial Sepsis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | White Blood Cell Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Cellulitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Albuminuria | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Infection | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Anorexia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pneumonia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pulmonary Embolism | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Dehydration | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Anaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Renal Failure | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Febrile Nutropenia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hyperglycaemia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Leukopenia | 3 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Rash | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hypoalbuminaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Neutropenia | 12 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Chronic Obstructive Pulmonary Disease | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Thrombocytopenia | 5 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hypocalcaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pulmonary Haemorrhage | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hyponatraemia | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Fatigue | 3 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Dyspnoea | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pain | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Arthralgia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hepatic Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hypertension | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Drug Hypersensitivity | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Back Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Hypersensitivity | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Collapse of Lung | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Pleural Effusion | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Aspartate Aminotransferase Increased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Musculoskeletal Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Blood Alkaline Phosphatase Increased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Leukocytoclastic Vasculitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Incidence of Grade ≥ 3 Adverse Events | Fibrin D Dimer Increased | 0 participants |
Secondary
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Time frame: 60 days following the last administration of study treatment
Population: Treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Asthenia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Nutrophil Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Back Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Anaemia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Lung Cancer Metastatic | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Gastric Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Bacterial Sepsis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Non-Small Cell Lung Cancer | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Fatigue | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Confusional State | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Thrombocytopenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Renal Failure | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pleural Effusion | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Febrile Neutropenia | 4 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pneumothorax | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Hepatic Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Chronic Obstructive Pulmonary Disease | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Cardiac Arrest | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pulmonary Embolism | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Drug Hypersensitivity | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Dyspnoea | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Dehydration | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Haemoptysis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Collapse of Lung | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pneumonitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Diarrhoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Pulmonary Haemorrhage | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Platelet Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Nasal Septum Perforation | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Neutropenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Aortic Aneurysm | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Haemoglobin Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Hypotension | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Serious Adverse Events | Cellulitis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Hypotension | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Cellulitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Bacterial Sepsis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Nutrophil Count Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Anaemia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Febrile Neutropenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Dehydration | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Neutropenia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Thrombocytopenia | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Cardiac Arrest | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Diarrhoea | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Asthenia | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Disease Progression | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Fatigue | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Hepatic Pain | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Drug Hypersensitivity | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Collapse of Lung | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Platelet Count Decreased | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Haemoglobin Decreased | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Back Pain | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Lung Cancer Metastatic | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Gastric Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Non-Small Cell Lung Cancer | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Confusional State | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Renal Failure | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pleural Effusion | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pneumothorax | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Chronic Obstructive Pulmonary Disease | 2 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pulmonary Embolism | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Dyspnoea | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Haemoptysis | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pneumonitis | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Pulmonary Haemorrhage | 1 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Nasal Septum Perforation | 0 participants |
| Bevacizumab + Carboplatin/Paclitaxel | Serious Adverse Events | Aortic Aneurysm | 0 participants |