Investigational Agent AG-013736 In Combinations With Stan... | NCT00454649 | Trialant
NCT00454649
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 4, 2012Estimated
Enrollment
102Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib + Paclitaxel (Cohort 4)
Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Axitinib + Docetaxel (Cohort 5)
Axitinib + Capecitabine (Cohort 6)
Axitinib + Capecitabine (Cohort 7)
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Countries
United States
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT00454649
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4061019
Secondary IDs
Not provided
Brief Title
Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
Official Title
A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2005
Primary Completion Date
Aug 2009Actual
Completion Date
Apr 2011Actual
First Submitted Date
Mar 29, 2007
First Submission Date that Met QC Criteria
Mar 30, 2007
First Posted Date
Apr 2, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 25, 2012
Results First Submitted that Met QC Criteria
Feb 25, 2012
Results First Posted Date
Mar 27, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 30, 2012
Last Update Posted Date
Apr 4, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
axitinib
chemotherapy
anti-angiogenesis
VEGF inhibition
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
102Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Axitinib [AG-013736] + chemotherapy combination
Experimental
The following separate groups were included:
axitinib
plus carboplatin/paclitaxel in three different schedules
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin
Exclusion Criteria:
Tumors abutting or providing support for blood vessels
Any significant gastrointestinal abnormalities or active bleeding.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Augusta
Georgia
30909
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 102 participants were enrolled for the study. Out of those, 4 participants were screen failure and were not included in results analysis.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
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
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Drug
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Paclitaxel (Cohort 4)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Docetaxel (Cohort 5)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Capecitabine (Cohort 6)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Capecitabine (Cohort 7)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Drug
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Axitinib [AG-013736] + chemotherapy combination
Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Maximum Observed Plasma Concentration (Cmax) for Paclitaxel
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Plasma Clearance (CL) for Paclitaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Plasma Decay Half Life (t1/2) for Paclitaxel
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Maximum Observed Plasma Concentration (Cmax) for Docetaxel
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Plasma Clearance (CL) for Docetaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Plasma Decay Half Life (t1/2) for Docetaxel
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Maximum Observed Plasma Concentration (Cmax) for Capecitabine
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Apparent Oral Clearance (CL/F) for Capecitabine
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Plasma Decay Half Life (t1/2) for Capecitabine
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Plasma Clearance (CL) for Gemcitabine
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Plasma Decay Half Life (t1/2) for Gemcitabine
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Maximum Observed Plasma Concentration (Cmax) for Carboplatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Plasma Clearance (CL) for Carboplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Plasma Decay Half Life (t1/2) for Carboplatin
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin
AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Maximum Observed Plasma Concentration (Cmax) for Cisplatin
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Plasma Clearance (CL) for Cisplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Plasma Decay Half Life (t1/2) for Cisplatin
t1/2 is the time measured for the plasma concentration to decrease by one half.
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Plasma Clearance (CL) for Pemetrexed
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Plasma Decay Half Life (t1/2) for Pemetrexed
t1/2 is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks
Augusta
Georgia
30912
United States
Pfizer Investigational Site
Harvey
Illinois
60426-4265
United States
Pfizer Investigational Site
Harvey
Illinois
60426
United States
Pfizer Investigational Site
Tinley Park
Illinois
60477
United States
Pfizer Investigational Site
Hobart
Indiana
46342
United States
Pfizer Investigational Site
Munster
Indiana
46321
United States
Pfizer Investigational Site
Philadelphia
Pennsylvania
19111
United States
Pfizer Investigational Site
Houston
Texas
77030-4009
United States
Pfizer Investigational Site
Kennewick
Washington
99336
United States
Pfizer Investigational Site
Warsaw
02-781
Poland
Pfizer Investigational Site
Barcelona
Barcelona
08003
Spain
Pfizer Investigational Site
Madrid
Madrid
28046
Spain
FG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
FG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
FG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
FG004
Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
FG005
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
FG006
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
FG007
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
FG008
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
FG009
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
FG0003 subjects
FG0015 subjects
FG00220 subjects
FG0037 subjects
FG0041 subjects
FG0057 subjects
FG0069 subjects
FG00719 subjects
FG00821 subjects
FG0096 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG00219 subjects
FG0036 subjects
FG0041 subjects
FG0057 subjects
FG0069 subjects
FG00719 subjects
FG00820 subjects
FG0095 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0002 subjects
FG0012 subjects
FG00210 subjects
FG0033 subjects
FG0040 subjects
FG0054 subjects
FG0065 subjects
FG00713 subjects
FG00810 subjects
FG0092 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
BG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
BG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
BG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
BG004
Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
BG005
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
BG006
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
BG007
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
BG008
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
BG009
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0015
BG00220
BG0037
BG0041
BG0057
BG0069
BG00719
BG00821
BG0096
BG01098
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
BG00061± 11.4
BG00162± 16.6
BG00259.5± 10.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
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
Primary
Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Safety analysis population included all enrolled participants who received at least 1 dose of study medication.
Posted
Number
mg BID
Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG0003
OG0015
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0015
OG0025
OG003
Secondary
Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
nanogram*hour/milliliter (ng*hr/mL)
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Secondary
Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)
Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Secondary
Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Liter/hour (L/hr)
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Secondary
Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
ID
Title
Description
OG000
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Combined Data from all participants in cohort 1, 2 and 3.
Secondary
Maximum Observed Plasma Concentration (Cmax) for Paclitaxel
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
ID
Title
Description
OG000
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel
Cmin was analyzed only for orally administered drugs.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
ID
Title
Description
OG000
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
OG000
Secondary
Plasma Clearance (CL) for Paclitaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
ID
Title
Description
OG000
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Combined Data from all participants in cohort 1, 2 and 3.
Secondary
Plasma Decay Half Life (t1/2) for Paclitaxel
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4
ID
Title
Description
OG000
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
ID
Title
Description
OG000
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) for Docetaxel
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
ID
Title
Description
OG000
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel
Cmin was analyzed only for orally administered drugs.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
ID
Title
Description
OG000
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Clearance (CL) for Docetaxel
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
ID
Title
Description
OG000
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Decay Half Life (t1/2) for Docetaxel
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5
ID
Title
Description
OG000
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine
AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
ID
Title
Description
OG000
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG001
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Units
Secondary
Maximum Observed Plasma Concentration (Cmax) for Capecitabine
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
ID
Title
Description
OG000
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG001
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Units
Counts
Participants
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine
Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
ID
Title
Description
OG000
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG001
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Units
Counts
Participants
OG000
Secondary
Apparent Oral Clearance (CL/F) for Capecitabine
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Liter/hr
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
ID
Title
Description
OG000
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG001
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Secondary
Plasma Decay Half Life (t1/2) for Capecitabine
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7
ID
Title
Description
OG000
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG001
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
Units
Counts
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) for Gemcitabine
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine
Cmin was analyzed only for orally administered drugs.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Clearance (CL) for Gemcitabine
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Decay Half Life (t1/2) for Gemcitabine
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) for Carboplatin
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
OG0000
Secondary
Plasma Clearance (CL) for Carboplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
OG000
Secondary
Plasma Decay Half Life (t1/2) for Carboplatin
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3
Combined Data from all participants in cohort 1, 2 and 3.
Units
Counts
Participants
OG000
Secondary
Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin
AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG001
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Secondary
Maximum Observed Plasma Concentration (Cmax) for Cisplatin
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG001
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin
Cmin was analyzed only for orally administered drugs.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG001
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
Secondary
Plasma Clearance (CL) for Cisplatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG001
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Secondary
Plasma Decay Half Life (t1/2) for Cisplatin
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9
ID
Title
Description
OG000
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG001
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng*hr/mL
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
ID
Title
Description
OG000
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) for Pemetrexed
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
ID
Title
Description
OG000
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed
Cmin was analyzed only for orally administered drugs.
Posted
Mean
Standard Deviation
ng/mL
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
ID
Title
Description
OG000
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Clearance (CL) for Pemetrexed
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
L/hr
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
ID
Title
Description
OG000
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Plasma Decay Half Life (t1/2) for Pemetrexed
t1/2 is the time measured for the plasma concentration to decrease by one half.
The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hr
0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9
ID
Title
Description
OG000
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Population included all participants who received at least 1 dose of study medication and had at least 1 target lesion according to RECIST and a baseline assessment of disease.
Posted
Number
Percentage of Participants
Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks
ID
Title
Description
OG000
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
OG001
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
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
Axitinib + Paclitaxel + Carboplatin (Cohort 1)
Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
2
3
3
3
EG001
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
2
5
5
5
EG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
11
20
20
20
EG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
2
7
7
7
EG004
Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1
1
1
1
EG005
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
4
7
7
7
EG006
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
6
9
9
9
EG007
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
9
19
19
19
EG008
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
13
21
21
21
EG009
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
4
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG0030 affected7 at risk
EG0040 affected1 at risk
EG0050 affected7 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
EG0081 affected21 at risk
EG0091 affected6 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Granulocytopenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Asthenia
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Chest pain
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Disease progression
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Drug interaction
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Fatigue
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pain
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Catheter related infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Localised infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Septic shock
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0014 affected5 at risk
EG0025 affected20 at risk
EG0030 affected7 at risk
EG0040 affected1 at risk
EG0052 affected7 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
EG00810 affected21 at risk
EG0091 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected5 at risk
EG0027 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0025 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cardiac flutter
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0020 affected20 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Thyroid disorder
Endocrine disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Astigmatism
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Diplopia
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dry eye
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Vision blurred
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Visual impairment
Eye disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected5 at risk
EG0023 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected5 at risk
EG0027 affected20 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0015 affected5 at risk
EG0025 affected20 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected5 at risk
EG0021 affected20 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Tongue oedema
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0023 affected20 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Asthenia
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0023 affected20 at risk
EG003
Catheter site pain
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Chest discomfort
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Chest pain
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0025 affected20 at risk
EG003
Chills
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0021 affected20 at risk
EG003
Fatigue
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0014 affected5 at risk
EG0029 affected20 at risk
EG003
General physical health deterioration
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Injection site reaction
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Malaise
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Oedema
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Pain
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0023 affected20 at risk
EG003
Therapeutic response unexpected
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Thirst
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Visceral oedema
General disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Abscess
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Catheter related infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gingival infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0023 affected20 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Localised infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Lung infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Nail bed infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Paronychia
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Sepsis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Skin infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Viral infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Bacteria urine identified
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Blood culture positive
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Blood urea increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Eosinophils urine present
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Fibrin D dimer
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Haemoglobin increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Neutrophil count
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Weight increased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
White blood cell count
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0014 affected5 at risk
EG0029 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected5 at risk
EG0022 affected20 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hyperalbuminaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0023 affected20 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected5 at risk
EG0027 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0021 affected20 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0026 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0021 affected20 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Autonomic neuropathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0023 affected20 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0024 affected20 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0025 affected20 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Leukoencephalopathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Monoplegia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected5 at risk
EG0024 affected20 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0023 affected20 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Tremor
Nervous system disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Anger
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Depression
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected5 at risk
EG0025 affected20 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0023 affected20 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Breast discomfort
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0027 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected5 at risk
EG0024 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0014 affected5 at risk
EG0023 affected20 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected5 at risk
EG0022 affected20 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Oropharyngeal blistering
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pulmonary cavitation
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0014 affected5 at risk
EG0029 affected20 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Hypoaesthesia facial
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected5 at risk
EG0025 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0021 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected5 at risk
EG0027 affected20 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0021 affected20 at risk
EG003
Catheter removal
Surgical and medical procedures
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Flushing
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected5 at risk
EG0020 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Hot flush
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected5 at risk
EG0025 affected20 at risk
EG003
Hypotension
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected5 at risk
EG0022 affected20 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (12.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected5 at risk
EG0020 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077784
Axitinib
D017239
Paclitaxel
D016190
Carboplatin
D000077143
Docetaxel
D000069287
Capecitabine
D000093542
Gemcitabine
D002945
Cisplatin
D000068437
Pemetrexed
Ancestor Terms
ID
Term
D001549
Benzamides
D000577
Amides
D009930
Organic Chemicals
D001565
Benzoates
D000146
Acids, Carbocyclic
D002264
Carboxylic Acids
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D007191
Indazoles
D011720
Pyrazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D004224
Diterpenes
D013729
Terpenes
D056831
Coordination Complexes
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D005472
Fluorouracil
D014498
Uracil
D011744
Pyrimidinones
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D017606
Chlorine Compounds
D007287
Inorganic Chemicals
D017672
Nitrogen Compounds
D017671
Platinum Compounds
D006147
Guanine
D007042
Hypoxanthines
D011688
Purinones
D011687
Purines
D005971
Glutamates
D024342
Amino Acids, Acidic
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
D000600
Amino Acids, Dicarboxylic
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0063 subjects
FG0074 subjects
FG0086 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0091 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
60.7
± 10.2
BG00464± NAStandard deviation was not calculated as only one participant was evaluable.
BG00563.4± 11.9
BG00660.4± 12.4
BG00753.4± 10.6
BG00854± 10.3
BG00958.8± 9.0
BG01057.8± 11.1
3
BG0033
BG0041
BG0055
BG0065
BG00711
BG00812
BG0093
BG01047
Male
BG0001
BG0013
BG00217
BG0034
BG0040
BG0052
BG0064
BG0078
BG0089
BG0093
BG01051
7
OG0047
OG0059
OG00619
OG00721
OG0086
5
OG004NAAxitinib (AG-013736) 5 mg BID was determined to be above the MTD.
OG0055
OG0065
OG0075
OG0085
AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG0033
OG0046
OG0056
OG0069
OG00715
OG0083
Title
Denominators
Categories
Title
Measurements
OG00061.58± 54.66
OG001242.41± 132.24
OG002475.18± 380.13
OG003154.43± 28.93
OG004780.99± 535.30
OG005365.95± 143.13
OG006449.99± 323.59
OG007416.30± 450.43
OG008420.64± 200.32
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG0003
OG0015
OG0026
OG0035
OG0047
OG0057
OG00615
OG00720
OG0084
Title
Denominators
Categories
Title
Measurements
OG0005.97± 2.59
OG00123.36± 8.08
OG00242.58± 18.25
OG00344.58± 44.78
OG00467.96± 39.24
OG00537.51± 15.31
OG00643.97± 28.82
OG00740.97± 33.06
OG00831.53± 22.87
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG0033
OG0046
OG0056
OG0069
OG00715
OG0083
Title
Denominators
Categories
Title
Measurements
OG00049.39± 34.46
OG00140.72± 46.75
OG00229.73± 18.49
OG00365.69± 11.94
OG00414.35± 7.67
OG00526.64± 15.58
OG00683.46± 171.05
OG00750.05± 56.75
OG00825.10± 21.31
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Units
Counts
Participants
OG0003
OG0015
OG0024
OG0033
OG0046
OG0056
OG0069
OG00715
OG0083
Title
Denominators
Categories
Title
Measurements
OG0002.75± 2.06
OG0012.90± 1.78
OG0022.80± 1.04
OG0031.45± 0.27
OG0044.07± 2.60
OG0053.85± 1.93
OG0063.64± 2.03
OG0072.68± 1.09
OG0085.02± 3.38
Units
Counts
Participants
OG0006
OG00112
Title
Denominators
Categories
Title
Measurements
OG0005683.55± 1519.49
OG00119959.91± 5951.86
OG0006
OG00112
Title
Denominators
Categories
Title
Measurements
OG0003698.33± 1198.32
OG0016105.00± 2167.59
0
OG0010
Units
Counts
Participants
OG0006
OG00112
Title
Denominators
Categories
Title
Measurements
OG00030.48± 6.16
OG00121.61± 9.38
Participants
OG0006
OG00112
Title
Denominators
Categories
Title
Measurements
OG00012.51± 1.03
OG0018.36± 2.16
4
Title
Denominators
Categories
Title
Measurements
OG0003478.49± 870.12
5
Title
Denominators
Categories
Title
Measurements
OG0003130.00± 1106.23
0
4
Title
Denominators
Categories
Title
Measurements
OG00042.96± 6.04
4
Title
Denominators
Categories
Title
Measurements
OG00011.49± 0.97
Counts
Participants
OG0003
OG00113
Title
Denominators
Categories
Title
Measurements
OG00020534.52± 3797.63
OG00122163.88± 16881.96
OG0005
OG00116
Title
Denominators
Categories
Title
Measurements
OG00010808.00± 6173.62
OG00110588.38± 9954.76
0
OG0010
Units
Counts
Participants
OG0003
OG00113
Title
Denominators
Categories
Title
Measurements
OG000209.05± 24.29
OG001314.12± 247.27
Participants
OG0003
OG00113
Title
Denominators
Categories
Title
Measurements
OG0000.85± 0.90
OG0011.44± 3.05
17
Title
Denominators
Categories
Title
Measurements
OG00010991.16± 3099.28
17
Title
Denominators
Categories
Title
Measurements
OG00020635.29± 10656.86
0
17
Title
Denominators
Categories
Title
Measurements
OG000224.36± 74.45
17
Title
Denominators
Categories
Title
Measurements
OG0000.29± 0.07
12
Title
Denominators
Categories
Title
Measurements
OG00055580.26± 9689.44
12
Title
Denominators
Categories
Title
Measurements
OG00023383.33± 7170.75
12
Title
Denominators
Categories
Title
Measurements
OG00012.57± 3.99
12
Title
Denominators
Categories
Title
Measurements
OG0002.62± 0.55
Units
Counts
Participants
OG00012
OG0014
Title
Denominators
Categories
Title
Measurements
OG0002932.43± 929.69
OG0012703.92± 688.68
Participants
OG00013
OG0014
Title
Denominators
Categories
Title
Measurements
OG0001680.54± 628.63
OG0011176.00± 295.29
OG0000
OG0010
Units
Counts
Participants
OG00012
OG0014
Title
Denominators
Categories
Title
Measurements
OG00046.31± 14.57
OG00146.80± 14.92
Units
Counts
Participants
OG00012
OG0014
Title
Denominators
Categories
Title
Measurements
OG0002.61± 1.27
OG0013.91± 1.59
4
Title
Denominators
Categories
Title
Measurements
OG000133032.97± 40176.65
4
Title
Denominators
Categories
Title
Measurements
OG00083925.00± 35820.05
0
4
Title
Denominators
Categories
Title
Measurements
OG0007.26± 2.08
4
Title
Denominators
Categories
Title
Measurements
OG0002.77± 1.80
Axitinib + Paclitaxel + Carboplatin (Cohort 2)
Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG002
Axitinib + Paclitaxel + Carboplatin (Cohort 3)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
OG003
Axitinib + Paclitaxel (Cohort 4)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
OG004
Axitinib + Docetaxel (Cohort 5)
Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
OG005
Axitinib + Capecitabine (Cohort 6)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG006
Axitinib + Capecitabine (Cohort 7)
Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
OG007
Axitinib + Gemcitabine + Cisplatin (Cohort 8)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
OG008
Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.