A Safety and Efficacy Study of Carboplatin, Paclitaxel, B... | NCT00653939

NCT00653939

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Chemotherapy+Bevacizumab	Active Comparator	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.	Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab
Arm 2: Active Comparator+Fosbretabulin	Experimental	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.	Drug: Fosbretabulin Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Fosbretabulin	Drug	Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.	Arm 2: Active Comparator+Fosbretabulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) in the Intent-to-Treat Population	Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.	Six 21-day cycles

Secondary Outcomes

Measure	Description	Time Frame
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population	Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jai Balkissoon, MD, FACS	Mateon Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southbay Oncology Hematology		Campbell	California	95008	United States
Pacific Coast Hematology and Oncology Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3412321	Background	Lin CM, Singh SB, Chu PS, Dempcy RO, Schmidt JM, Pettit GR, Hamel E. Interactions of tubulin with potent natural and synthetic analogs of the antimitotic agent combretastatin: a structure-activity study. Mol Pharmacol. 1988 Aug;34(2):200-8.
17167137	Background	Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Combretastatin A4 Phosphate
Zybrestat
CA4P

FG00031 subjects2 patients randomized did not receive treatment due to brain metastasis or consent withdrawal.

FG00132 subjects1 patient randomized did not receive treatment due to acute renal failure.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
BG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00131 BG00260

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.5± 9.5 BG00161.0± 9.4 BG00262.2± 9.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG00112 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00029 BG00131 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Number

participants

Title

Denominators

Categories

0 - Fully active

Title	Measurements
	BG00016 BG00116 BG002

Surgery Performed

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0005 BG0014 BG002

Prior Surgery Due to NSCLC

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0003 BG0012 BG002

Subject Given Radiation Therapy

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0005 BG0014 BG002

Prior Radiation Due to NSCLC

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG0004 BG0014 BG002

Stage of Disease at Study Entry

Number

participants

Title

Denominators

Categories

IIIB

Title	Measurements
	BG0004 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population

Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.

Intent-to-Treat

Posted

Number

participants

Six 21-day cycles

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Units	Counts
Participants	OG00031 OG00132

Title

Denominators

Categories

Complete Response

Title	Measurements
	OG0000 OG0010

Partial Response

Title	Measurements
	OG000

Secondary

Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population

Intent-to-Treat

Posted

Median

95% Confidence Interval

Months

Until death or lost to follow-up, up to 12 months since randomization

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Primary

Progression Free Survival (PFS) in the Intent-to-Treat Population

Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.

Intent-to-Treat

Posted

Median

95% Confidence Interval

months

Six 21-day cycles

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Secondary

Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)

Safety Population

Posted

Number

participants

Days 1 (pretreatment) per 21-day Cycle (6 Cycles)

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Secondary

Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)

Safety Population

Posted

Number

participants

Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Secondary

Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)

Safety Population

Posted

Number

participants

Day 1 (pretreatment) per 21-day Cycle (6 Cycles)

ID	Title	Description
OG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
OG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1: Chemotherapy+Bevacizumab	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.			16	29	29	29
EG001	Arm 2: Active Comparator+Fosbretabulin	Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.			16	31	31	31

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Neutropenia	Blood and lymphatic system disorders	EG0001 affected29 at risk EG0011 affected31 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Myocardial Infarction	Cardiac disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Myocardial Ischaemia	Cardiac disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Colitis Ischaemic	Gastrointestinal disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Constipation	Gastrointestinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Diarrhoea	Gastrointestinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Asthenia	General disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Disease Progression	General disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Fatigue	General disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Infusion Site Thrombosis	General disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Non-cardiac Chest Pain	General disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Pyrexia	General disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Cholelithiasis	Hepatobiliary disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Arthritis Infective	Infections and infestations	EG0001 affected29 at risk EG0010 affected31 at risk
Bronchitis	Infections and infestations	EG0000 affected29 at risk EG0011 affected31 at risk
Lung Abscess	Infections and infestations	EG0001 affected29 at risk EG0010 affected31 at risk
Pneumonia	Infections and infestations	EG0002 affected29 at risk EG0010 affected31 at risk
Pseudomonal Bacteraemia	Infections and infestations	EG0001 affected29 at risk EG0010 affected31 at risk
Sepsis	Infections and infestations	EG0001 affected29 at risk EG0010 affected31 at risk
Dehydration	Metabolism and nutrition disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Failure to Thrive	Metabolism and nutrition disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0001 affected29 at risk EG0011 affected31 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Metastases to Meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected29 at risk EG0012 affected31 at risk
Cerbral Infarction	Nervous system disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Cerebrovascular Accident	Nervous system disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Spinal Cord Compression	Nervous system disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Delirium	Psychiatric disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Mental Status Changes	Psychiatric disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Hydronephrosis	Renal and urinary disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Renal Failure	Renal and urinary disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Urinary Retention	Renal and urinary disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Pelvic Pain	Reproductive system and breast disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Epixtaxis	Respiratory, thoracic and mediastinal disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	EG0001 affected29 at risk EG0011 affected31 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0001 affected29 at risk EG0013 affected31 at risk
Repiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Deep Vein Thrombosis	Vascular disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Hypertension	Vascular disorders	EG0001 affected29 at risk EG0010 affected31 at risk
Hypotension	Vascular disorders	EG0000 affected29 at risk EG0011 affected31 at risk
Thrombophlebitis	Vascular disorders	EG0000 affected29 at risk EG0011 affected31 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Neutropenia	Blood and lymphatic system disorders	EG00014 affected29 at risk EG00125 affected31 at risk
Anaemia	Blood and lymphatic system disorders	EG00020 affected29 at risk EG00113 affected31 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG00018 affected29 at risk EG00113 affected31 at risk
Leukopenia	Blood and lymphatic system disorders	EG0007 affected29 at risk EG00114 affected31 at risk
Leukocytosis	Blood and lymphatic system disorders	EG0003 affected29 at risk EG0011 affected31 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0000 affected29 at risk EG0013 affected31 at risk
Lymphopenia	Blood and lymphatic system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Nausea	Gastrointestinal disorders	EG00020 affected29 at risk EG00113 affected31 at risk
Diarrhoea	Gastrointestinal disorders	EG00017 affected29 at risk EG00111 affected31 at risk
Constipation	Gastrointestinal disorders	EG00011 affected29 at risk EG00111 affected31 at risk
Vomiting	Gastrointestinal disorders	EG00011 affected29 at risk EG0017 affected31 at risk
Abdominal Pain	Gastrointestinal disorders	EG0005 affected29 at risk EG0015 affected31 at risk
Stomatitis	Gastrointestinal disorders	EG0003 affected29 at risk EG0015 affected31 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	EG0005 affected29 at risk EG0011 affected31 at risk
Gingival Bleeding	Gastrointestinal disorders	EG0003 affected29 at risk EG0012 affected31 at risk
Toothache	Gastrointestinal disorders	EG0004 affected29 at risk EG0010 affected31 at risk
Abdominal Discomfort	Gastrointestinal disorders	EG0000 affected29 at risk EG0013 affected31 at risk
Dyspepsia	Gastrointestinal disorders	EG0001 affected29 at risk EG0012 affected31 at risk
Oral Pain	Gastrointestinal disorders	EG0001 affected29 at risk EG0012 affected31 at risk
Cheilitis	Gastrointestinal disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Gastritis	Gastrointestinal disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Haemorrhoids	Gastrointestinal disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Fatigue	General disorders	EG00025 affected29 at risk EG00118 affected31 at risk
Pyrexia	General disorders	EG00010 affected29 at risk EG0016 affected31 at risk
Oedema peripheral	General disorders	EG0006 affected29 at risk EG0018 affected31 at risk
Asthenia	General disorders	EG0006 affected29 at risk EG0014 affected31 at risk
Chest Discomfort	General disorders	EG0002 affected29 at risk EG0015 affected31 at risk
Chills	General disorders	EG0003 affected29 at risk EG0012 affected31 at risk
Gait Disturbance	General disorders	EG0002 affected29 at risk EG0013 affected31 at risk
Non-cardiac Chest Pain	General disorders	EG0002 affected29 at risk EG0013 affected31 at risk
Mucosal Inflammation	General disorders	EG0001 affected29 at risk EG0013 affected31 at risk
Pain	General disorders	EG0003 affected29 at risk EG0011 affected31 at risk
Chest Pain	General disorders	EG0001 affected29 at risk EG0012 affected31 at risk
Infusion Site Pain	General disorders	EG0000 affected29 at risk EG0013 affected31 at risk
Adverse Drug Reaction	General disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Neuropathy	Nervous system disorders	EG00019 affected29 at risk EG00115 affected31 at risk
Headache	Nervous system disorders	EG00012 affected29 at risk EG0014 affected31 at risk
Dizziness	Nervous system disorders	EG0009 affected29 at risk EG0013 affected31 at risk
Hypoaesthesia	Nervous system disorders	EG0003 affected29 at risk EG0016 affected31 at risk
Dysgeusia	Nervous system disorders	EG0003 affected29 at risk EG0013 affected31 at risk
Burning Sensation	Nervous system disorders	EG0001 affected29 at risk EG0013 affected31 at risk
Syncope	Nervous system disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Amnesia	Nervous system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Balance Disorder	Nervous system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Memory Impairment	Nervous system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Paraesthesia	Nervous system disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG00010 affected29 at risk EG0013 affected31 at risk
Anorexia	Metabolism and nutrition disorders	EG0009 affected29 at risk EG0013 affected31 at risk
Decreased Appetite	Metabolism and nutrition disorders	EG0005 affected29 at risk EG0016 affected31 at risk
Dehydration	Metabolism and nutrition disorders	EG0008 affected29 at risk EG0013 affected31 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0005 affected29 at risk EG0012 affected31 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0002 affected29 at risk EG0015 affected31 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0002 affected29 at risk EG0014 affected31 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00016 affected29 at risk EG00111 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00011 affected29 at risk EG0019 affected31 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0007 affected29 at risk EG0018 affected31 at risk
Pharyngolarygeal Pain	Respiratory, thoracic and mediastinal disorders	EG0009 affected29 at risk EG0014 affected31 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	EG0005 affected29 at risk EG0013 affected31 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG0002 affected29 at risk EG0015 affected31 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	EG0003 affected29 at risk EG0012 affected31 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0004 affected29 at risk EG0010 affected31 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0001 affected29 at risk EG0013 affected31 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	EG0003 affected29 at risk EG0010 affected31 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG00010 affected29 at risk EG0017 affected31 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0007 affected29 at risk EG0017 affected31 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0004 affected29 at risk EG0019 affected31 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	EG0006 affected29 at risk EG0016 affected31 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0006 affected29 at risk EG0015 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0005 affected29 at risk EG0016 affected31 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0004 affected29 at risk EG0014 affected31 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0003 affected29 at risk EG0012 affected31 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	EG0001 affected29 at risk EG0013 affected31 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG00016 affected29 at risk EG00113 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	EG0007 affected29 at risk EG0017 affected31 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG0002 affected29 at risk EG0014 affected31 at risk
Dry Skin	Skin and subcutaneous tissue disorders	EG0003 affected29 at risk EG0011 affected31 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Night Sweats	Skin and subcutaneous tissue disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Pain of Skin	Skin and subcutaneous tissue disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Upper Respiratory Tract Infections	Infections and infestations	EG0004 affected29 at risk EG0015 affected31 at risk
Urinary Tract Infection	Infections and infestations	EG0006 affected29 at risk EG0013 affected31 at risk
Bronchitis	Infections and infestations	EG0004 affected29 at risk EG0011 affected31 at risk
Nasopharyngitis	Infections and infestations	EG0004 affected29 at risk EG0011 affected31 at risk
Pneumonia	Infections and infestations	EG0004 affected29 at risk EG0010 affected31 at risk
Catheter Site Infection	Infections and infestations	EG0002 affected29 at risk EG0011 affected31 at risk
Cellulitis	Infections and infestations	EG0002 affected29 at risk EG0011 affected31 at risk
Fungal Infection	Infections and infestations	EG0003 affected29 at risk EG0010 affected31 at risk
Sinusitis	Infections and infestations	EG0001 affected29 at risk EG0012 affected31 at risk
Oral Candidiasis	Infections and infestations	EG0002 affected29 at risk EG0010 affected31 at risk
Tooth Infection	Infections and infestations	EG0000 affected29 at risk EG0012 affected31 at risk
Hypertension	Vascular disorders	EG00013 affected29 at risk EG00117 affected31 at risk
Hypotension	Vascular disorders	EG0007 affected29 at risk EG0011 affected31 at risk
Flushing	Vascular disorders	EG0001 affected29 at risk EG0014 affected31 at risk
Orthostatic Hypotension	Vascular disorders	EG0005 affected29 at risk EG0010 affected31 at risk
Deep Vein Thrombosis	Vascular disorders	EG0000 affected29 at risk EG0013 affected31 at risk
Weight Decreased	Investigations	EG0008 affected29 at risk EG0013 affected31 at risk
Alanine Aminotransferase Increased	Investigations	EG0003 affected29 at risk EG0011 affected31 at risk
Breath Sounds Abnormal	Investigations	EG0001 affected29 at risk EG0013 affected31 at risk
Gamma-glutamyltransferase Increased	Investigations	EG0002 affected29 at risk EG0012 affected31 at risk
Blood Chloride Decreased	Investigations	EG0000 affected29 at risk EG0012 affected31 at risk
Blood Lactate Dehydrogenase Increased	Investigations	EG0000 affected29 at risk EG0012 affected31 at risk
Blood Urea Increased	Investigations	EG0002 affected29 at risk EG0010 affected31 at risk
Electrocardiogram T Wave Abnormal	Investigations	EG0000 affected29 at risk EG0012 affected31 at risk
Oxygen Saturation Decreased	Investigations	EG0002 affected29 at risk EG0010 affected31 at risk
Prothrombin Time Prolonged	Investigations	EG0000 affected29 at risk EG0012 affected31 at risk
Insomnia	Psychiatric disorders	EG0005 affected29 at risk EG0017 affected31 at risk
Depression	Psychiatric disorders	EG0004 affected29 at risk EG0016 affected31 at risk
Anxiety	Psychiatric disorders	EG0003 affected29 at risk EG0012 affected31 at risk
Confusional State	Psychiatric disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Delirium	Psychiatric disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Tachycardia	Cardiac disorders	EG0003 affected29 at risk EG0018 affected31 at risk
Bradycardia	Cardiac disorders	EG0000 affected29 at risk EG0014 affected31 at risk
Angina Pectoris	Cardiac disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Coronary Artery Disease	Cardiac disorders	EG0001 affected29 at risk EG0012 affected31 at risk
Myocardial Ischaemia	Cardiac disorders	EG0000 affected29 at risk EG0013 affected31 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Ventricular Extrasystoles	Cardiac disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Proteinuria	Renal and urinary disorders	EG0005 affected29 at risk EG0013 affected31 at risk
Haematuria	Renal and urinary disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Urinary Retention	Renal and urinary disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Vision Blurred	Eye disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Fall	Injury, poisoning and procedural complications	EG0002 affected29 at risk EG0011 affected31 at risk
Ear Pain	Ear and labyrinth disorders	EG0002 affected29 at risk EG0012 affected31 at risk
Hypoacusis	Ear and labyrinth disorders	EG0000 affected29 at risk EG0012 affected31 at risk
Drug Hypersensitivity	Immune system disorders	EG0001 affected29 at risk EG0012 affected31 at risk
Metastases to Meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected29 at risk EG0012 affected31 at risk
Prostatitis	Reproductive system and breast disorders	EG0002 affected29 at risk EG0010 affected31 at risk
Endocrine Disorders	Endocrine disorders	EG0002 affected29 at risk EG0011 affected31 at risk
Hepatobiliary Disorders	Hepatobiliary disorders	EG0001 affected29 at risk EG0012 affected31 at risk

ID	Term
D009369	Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C058728	fosbretabulin
D016190	Carboplatin
D017239	Paclitaxel
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins