Study With AG-013736 Combined With Chemotherapy And Bevac... | NCT00460603 | Trialant
NCT00460603
Sponsor
Pfizer
Status
Completed
Last Update Posted
Dec 6, 2013Estimated
Enrollment
187Actual
Phase
Phase 1Phase 2
Conditions
Colorectal Neoplasms
Interventions
bevacizumab
AG-013726
AG-013736 (axitinib)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00460603
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4061020
Secondary IDs
Not provided
Brief Title
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Official Title
A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2013
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
Jan 2006
Primary Completion Date
Apr 2012Actual
Completion Date
Nov 2012Actual
First Submitted Date
Apr 13, 2007
First Submission Date that Met QC Criteria
Apr 13, 2007
First Posted Date
Apr 16, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 28, 2013
Results First Submitted that Met QC Criteria
Jun 3, 2013
Results First Posted Date
Jun 4, 2013Estimated
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
Nov 7, 2013
Last Update Posted Date
Dec 6, 2013Estimated
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 safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.
Percentage of Participants With Objective Response: Phase 2
Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
(Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
(Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was > 12 months prior to enrollment,
Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.
Exclusion Criteria:
Prior system therapy for advanced CRC (Ph 2 portion only)
Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed > 2 weeks of enrollment and be fully recovered from any procedure.
Hoh CK, Burris HA 3rd, Bendell JC, Tarazi J, Rosbrook B, Kim S, Infante JR, Reid TR. Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. Br J Cancer. 2014 Feb 18;110(4):875-81. doi: 10.1038/bjc.2013.806. Epub 2014 Jan 14.
Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Periods
Title
Milestones
Reasons Not Completed
Phase 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
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
Drug
AG-013726 5 mg bid every 2 weeks
C
AG-013736 (axitinib)
Drug
AG-013736 5 mg bid starting dose
A
Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1
PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Apparent Oral Clearance (CL/F) For Axitinib: Phase 1
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1
PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Clearance (CL) For Oxaliplatin: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1
PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Clearance (CL) For 5-Fluorouracil: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1
Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Clearance (CL) For Irinotecan: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1
PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Clearance (CL) For Bevacizumab: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Duration of Response (DR): Phase 2
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
Progression-Free Survival (PFS): Phase 2
Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
Time to Treatment Failure (TTF): Phase 2
TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
Overall Survival (OS): Phase 2
Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant
Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2
PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.
Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG003
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG004
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG005
Phase 1: Axitinib + FOLFIRI (Cohort 6)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG006
Phase 1: Axitinib + FOLFOX (Cohort 7)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG007
Phase 1: Axitinib + FOLFIRI (Cohort 8)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG008
Phase 1: Axitinib + FOLFIRI (Cohort 9)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG009
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG010
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
FG011
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG003
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG004
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG005
Phase 1: Axitinib + FOLFIRI (Cohort 6)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG006
Phase 1: Axitinib + FOLFOX (Cohort 7)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG007
Phase 1: Axitinib + FOLFIRI (Cohort 8)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG008
Phase 1: Axitinib + FOLFIRI (Cohort 9)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG009
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG010
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG011
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0024
BG0038
BG0046
BG0054
BG0066
BG0073
BG00818
BG00942
BG01043
BG01141
BG012187
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
Less than (<) 18 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
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
Percentage of Participants With Objective Response: Phase 2
Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG001
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00042
OG00143
OG00241
Title
Denominators
Categories
Title
Measurements
OG00028.6(15.7 to 44.6)
OG00148.8(33.3 to 64.5)
OG00239.0(24.2 to 55.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus [vs.] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.
Cochran-Mantel-Haenszel
0.9726
Risk Ratio (RR)
0.585
2-Sided
95
0.332
1.031
No
Superiority or Other
OG000
OG002
Secondary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
nanogram hour per milliliter (ng*hr/mL)
Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1
PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1
PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.
Posted
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Apparent Oral Clearance (CL/F) For Axitinib: Phase 1
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
Liter per hour (L/hr)
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hours
Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1
Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1
PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1
PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.
Posted
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Clearance (CL) For Oxaliplatin: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
L/hr
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hours
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1
PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1
PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.
Posted
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Clearance (CL) For 5-Fluorouracil: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
L/hr
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hours
Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1
Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1
PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.
Posted
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG000
Secondary
Clearance (CL) For Irinotecan: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
L/hr
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hours
Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
ID
Title
Description
OG000
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng*hr/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1
PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1
PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.
Posted
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
Secondary
Clearance (CL) For Bevacizumab: Phase 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
L/hr
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.
PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
hours
Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1
Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Duration of Response (DR): Phase 2
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure.
Posted
Median
95% Confidence Interval
days
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Progression-Free Survival (PFS): Phase 2
Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Posted
Median
95% Confidence Interval
days
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Time to Treatment Failure (TTF): Phase 2
TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.
ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Posted
Median
95% Confidence Interval
days
Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Secondary
Overall Survival (OS): Phase 2
Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Posted
Median
95% Confidence Interval
days
Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG001
Phase 2: Bevacizumab + FOLFOX
Secondary
Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2
PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.
ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Posted
Mean
Standard Deviation
units on scale
Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose
ID
Title
Description
OG000
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
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.
Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
2
4
4
4
EG003
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
3
8
8
8
EG004
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
5
6
6
6
EG005
Phase 1: Axitinib + FOLFIRI (Cohort 6)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1
4
4
4
EG006
Phase 1: Axitinib + FOLFOX (Cohort 7)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1
6
6
6
EG007
Phase 1: Axitinib + FOLFIRI (Cohort 8)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1
3
3
3
EG008
Phase 1: Axitinib + FOLFOX (Cohort 9)
Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
8
18
18
18
EG009
Phase 2: Axitinib + FOLFOX
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
15
39
39
39
EG010
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
17
43
42
43
EG011
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
23
41
39
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG0030 affected8 at risk
EG0040 affected6 at risk
EG0050 affected4 at risk
EG0060 affected6 at risk
EG0070 affected3 at risk
EG0080 affected18 at risk
EG0090 affected39 at risk
EG0100 affected43 at risk
EG0110 affected41 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blindness
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal stenosis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Disease progression
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Septic shock
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0022 affected4 at risk
EG0031 affected8 at risk
EG0042 affected6 at risk
EG0053 affected4 at risk
EG0061 affected6 at risk
EG0071 affected3 at risk
EG0085 affected18 at risk
EG0099 affected39 at risk
EG0109 affected43 at risk
EG01112 affected41 at risk
Anaemia megaloblastic
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypercoagulation
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Microcytosis
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected4 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0022 affected4 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected4 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Eye discharge
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Eye irritation
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0023 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0006 affected6 at risk
EG0014 affected6 at risk
EG0023 affected4 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected6 at risk
EG0021 affected4 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Catheter site erythema
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Catheter site haematoma
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Catheter site pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Chills
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected4 at risk
EG003
Device dislocation
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Device occlusion
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Early satiety
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Face oedema
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0005 affected6 at risk
EG0014 affected6 at risk
EG0024 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hernia pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Impaired healing
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Local swelling
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0006 affected6 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Nodule
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Oedema
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected4 at risk
EG003
Temperature intolerance
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Thrombosis in device
General disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Arthropod-borne disease
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected4 at risk
EG003
Candidiasis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Enterobacter sepsis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Eye infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Furuncle
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Incision site infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tinea infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Viral infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Anal injury
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Procedural site reaction
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Wound dehiscence
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood pressure diastolic decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood pressure increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cardiac enzymes increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0005 affected6 at risk
EG0014 affected6 at risk
EG0022 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0005 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bursa disorder
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ageusia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0022 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0011 affected6 at risk
EG0022 affected4 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mononeuritis
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0012 affected6 at risk
EG0024 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Claustrophobia
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0022 affected4 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urethral haemorrhage
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0004 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0022 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Nasal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0020 affected4 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected4 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Facial wasting
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0003 affected6 at risk
EG0012 affected6 at risk
EG0020 affected4 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Plantar erythema
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0006 affected6 at risk
EG0013 affected6 at risk
EG0024 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Pallor
Vascular disorders
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA (15.1)
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Time to Treatment Failure (TTF) was included as a secondary endpoint of the study after change in analysis plan.
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
D015179
Colorectal Neoplasms
Ancestor Terms
ID
Term
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068258
Bevacizumab
D000077784
Axitinib
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
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
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0063 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
2 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG00811 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
3 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00939 subjects
FG01043 subjects
FG01141 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00942 subjects
FG01043 subjects
FG01141 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00912 subjects
FG0109 subjects
FG01110 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0094 subjects
FG0102 subjects
FG0112 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0096 subjects
FG01016 subjects
FG0117 subjects
Objective Progression or Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0099 subjects
FG01010 subjects
FG01117 subjects
Global Deterioration of Health Status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0095 subjects
FG0104 subjects
FG0115 subjects
Randomized, but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0100 subjects
FG0110 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
18 to 44 years
Title
Measurements
BG0001
BG0012
BG0020
BG0031
BG0041
BG0051
BG0060
BG0070
BG0081
BG0092
BG0104
BG0118
BG01221
45 to 64 years
Title
Measurements
BG0002
BG0011
BG0023
BG0033
BG0042
BG0051
BG0065
BG0073
BG00813
BG00922
BG01018
BG01123
BG01296
Greater than or equal to (>=) 65 years
Title
Measurements
BG0003
BG0013
BG0021
BG0034
BG0043
BG0052
BG0061
BG0070
BG0084
BG00918
BG01021
BG01110
BG01270
2
BG0032
BG0041
BG0052
BG0062
BG0070
BG0087
BG00917
BG01015
BG01115
BG01267
Male
BG0003
BG0015
BG0022
BG0036
BG0045
BG0052
BG0064
BG0073
BG00811
BG00925
BG01028
BG01126
BG012120
One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.
Cochran-Mantel-Haenszel
0.8391
Risk Ratio (RR)
0.735
2-Sided
95
0.399
1.352
No
Superiority or Other
OG001
OG002
One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.
Cochran-Mantel-Haenszel
0.8192
Risk Ratio (RR)
0.797
2-Sided
95
0.489
1.299
No
Superiority or Other
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00012
OG0016
OG0026
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG000119.02(56.17 to 252.21)
OG001106.76(27.27 to 417.89)
OG00297.05(49.01 to 192.16)
Cycle 2 Day 1
Title
Measurements
OG00095.70(45.16 to 202.80)
OG001143.68(36.70 to 562.43)
OG002117.47(59.32 to 232.60)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0008
OG0014
OG0023
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG000190.51(77.99 to 465.35)
OG001113.20(8.89 to 1442.19)
OG002205.41(53.61 to 787.01)
Cycle 2 Day 1
Title
Measurements
OG000224.46(91.89 to 548.29)
OG001168.07(13.19 to 2141.15)
OG002178.46(46.58 to 683.73)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00012
OG0016
OG0026
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG00035.57(18.37 to 68.89)
OG00127.14(7.40 to 99.49)
OG00224.23(14.32 to 40.98)
Cycle 2 Day 1
Title
Measurements
OG00027.51(14.20 to 53.28)
OG00142.48(11.59 to 155.73)
OG00232.62(19.29 to 55.18)
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0008
OG0014
OG0023
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG00030.01(15.05 to 59.82)
OG00147.10(3.72 to 596.29)
OG00228.49(9.32 to 87.03)
Cycle 2 Day 1
Title
Measurements
OG00030.08(15.09 to 59.96)
OG00133.33(2.63 to 421.92)
OG00228.90(9.46 to 88.31)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0008
OG0014
OG0023
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG0003.26± 3.943
OG0012.23± 0.702
OG0023.47± 2.820
Cycle 2 Day 1
Title
Measurements
OG0006.12± 7.450
OG0013.09± 0.889
OG0021.73± 0.456
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00015
OG0015
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0004814.87(4079.46 to 5682.84)
OG0014308.71(2822.77 to 6576.87)
Cycle 2 Day 1
Title
Measurements
OG0005231.71(4432.64 to 6174.83)
OG0015303.66(3474.59 to 8095.57)
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00015
OG0015
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0005955.70(4615.41 to 7685.21)
OG0015137.31(3296.14 to 8006.93)
Cycle 2 Day 1
Title
Measurements
OG0006744.06(5226.35 to 8702.50)
OG0016430.67(4125.97 to 10022.74)
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00015
OG0015
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG000278.81(201.38 to 386.03)
OG001265.05(67.62 to 1038.93)
Cycle 2 Day 1
Title
Measurements
OG000318.99(230.40 to 441.66)
OG001374.03(95.42 to 1466.10)
Units
Counts
Participants
OG0000
OG0010
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00015
OG0015
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00027.51(21.56 to 35.11)
OG00130.74(18.48 to 51.13)
Cycle 2 Day 1
Title
Measurements
OG00024.29(19.04 to 31.00)
OG00124.56(14.76 to 40.85)
OG001
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00015
OG0015
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00020.63± 6.513
OG00118.38± 3.004
Cycle 2 Day 1
Title
Measurements
OG00023.30± 14.975
OG00119.86± 4.110
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00014
OG0017
OG0025
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00039212.03(22388.50 to 68677.39)
OG00140955.29(23831.07 to 70384.39)
OG00252164.28(4725.16 to 575877.57)
Cycle 2 Day 1
Title
Measurements
OG00045087.71(25743.27 to 78968.27)
OG00136533.84(21258.32 to 62785.83)
OG00295123.13(8616.47 to 1050129.94)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0009
OG0017
OG0025
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00036314.14(19623.50 to 67200.90)
OG00141460.50(23968.34 to 71718.51)
OG00252430.15(4751.38 to 578551.86)
Cycle 2 Day 1
Title
Measurements
OG00038983.80(21066.13 to 72141.23)
OG00136776.79(21260.68 to 63616.60)
OG00296632.41(8757.13 to 1066311.16)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00014
OG0017
OG0025
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00016160.85(6975.82 to 37439.78)
OG00134436.94(22763.46 to 52096.78)
OG00219622.74(2754.12 to 139809.41)
Cycle 2 Day 1
Title
Measurements
OG00016249.77(7014.20 to 37645.79)
OG00139730.46(26262.58 to 60104.90)
OG00234180.87(4797.41 to 243534.09)
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0009
OG0017
OG0025
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG000147.43(77.38 to 280.93)
OG001128.28(73.44 to 224.05)
OG00299.36(10.18 to 969.40)
Cycle 2 Day 1
Title
Measurements
OG000137.34(72.08 to 261.70)
OG001144.62(82.80 to 252.59)
OG00253.92(5.53 to 526.06)
OG001
Phase 1: Axitinib + FOLFIRI (Cohort 4)
FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 1: Axitinib + FOLFOX (Cohort 5)
FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG0009
OG0017
OG0025
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0000.26± 0.218
OG0010.19± 0.069
OG0020.39± 0.291
Cycle 2 Day 1
Title
Measurements
OG0000.25± 0.142
OG0010.14± 0.029
OG0020.24± 0.131
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00012081.58(8805.17 to 16577.15)
Cycle 2 Day 1
Title
Measurements
OG00011496.32(8378.62 to 15774.11)
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00013055.88(9371.39 to 18188.96)
Cycle 2 Day 1
Title
Measurements
OG00012459.89(8943.60 to 17358.66)
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0001910.25(1561.45 to 2336.97)
Cycle 2 Day 1
Title
Measurements
OG0001788.69(1462.08 to 2188.26)
0
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Cycle 1 Day 8
Title
Measurements
OG00026.09(18.10 to 37.61)
Cycle 2 Day 1
Title
Measurements
OG00027.34(18.97 to 39.40)
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0006.45± 1.406
Cycle 2 Day 1
Title
Measurements
OG0006.75± 0.886
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0003394758.83(2453600.72 to 4696928.65)
Cycle 2 Day 1
Title
Measurements
OG0003554899.52(2569344.23 to 4918496.49)
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0004987528.96(3395240.62 to 7326563.24)
Cycle 2 Day 1
Title
Measurements
OG0005114888.84(3481940.36 to 7513651.92)
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG00026460.05(19574.60 to 35767.50)
Cycle 2 Day 1
Title
Measurements
OG00026850.12(19863.16 to 36294.76)
OG000
0
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG0000.01(0.01 to 0.02)
Cycle 2 Day 1
Title
Measurements
OG0000.02(0.01 to 0.02)
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG000205.97± 46.454
Cycle 2 Day 1
Title
Measurements
OG000210.22± 55.317
OG001
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00012
OG00121
OG00216
Title
Denominators
Categories
Title
Measurements
OG000434.0(246.0 to 666.0)
OG001NA(232.0 to NA)Data was not estimable since high number of participants was censored for this measure.
OG002343.0(168.0 to 490.0)
OG001
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00042
OG00143
OG00241
Title
Denominators
Categories
Title
Measurements
OG000336(225.0 to 749.0)
OG001485(276.0 to NA)Data was not estimable since high number of participants was censored for this measure.
OG002381(238.0 to 425.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.5699
Hazard Ratio (HR)
1.08
2-Sided
95
0.47
2.45
No
Superiority or Other
OG000
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.2167
Hazard Ratio (HR)
0.73
2-Sided
95
0.33
1.61
No
Superiority or Other
OG001
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.8746
Hazard Ratio (HR)
1.49
2-Sided
95
0.75
2.98
No
Superiority or Other
OG001
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00042
OG00143
OG00241
Title
Denominators
Categories
Title
Measurements
OG000187.0(162.0 to 315.0)
OG001241.0(205.0 to 344.0)
OG002238.0(155.0 to 333.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.8884
Hazard Ratio (HR)
1.40
2-Sided
95
0.81
2.41
No
Superiority or Other
OG000
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.6648
Hazard Ratio (HR)
1.12
2-Sided
95
0.66
1.89
No
Superiority or Other
OG001
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.8065
Hazard Ratio (HR)
1.25
2-Sided
95
0.75
2.07
No
Superiority or Other
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00042
OG00143
OG00241
Title
Denominators
Categories
Title
Measurements
OG000552.0(443.0 to 911.0)
OG001659.0(493.0 to 899.0)
OG002601.0(533.0 to 882.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.6904
Hazard Ratio (HR)
1.155
2-Sided
95
0.656
2.033
No
Superiority or Other
OG000
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.7364
Hazard Ratio (HR)
1.203
2-Sided
95
0.676
2.141
No
Superiority or Other
OG001
OG002
Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).
Log Rank
0.4140
Hazard Ratio (HR)
0.941
2-Sided
95
0.535
1.653
No
Superiority or Other
OG001
Phase 2: Bevacizumab + FOLFOX
Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
OG002
Phase 2: Axitinib + Bevacizumab + FOLFOX
Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
Units
Counts
Participants
OG00042
OG00143
OG00241
Title
Denominators
Categories
Severity Scale: Baseline (n=41,43,40)
Title
Measurements
OG0001.62± 1.57
OG0012.20± 1.93
OG0022.18± 2.06
Severity Scale: C2D1 (n=37,37,37)
Title
Measurements
OG0000.63± 1.22
OG0010.04± 1.16
OG0020.80± 1.32
Severity Scale: C3D1 (n=32,38,32)
Title
Measurements
OG0000.68± 1.29
OG001-0.22± 1.17
OG0020.63± 1.61
Severity Scale: C4D1 (n=23,37,30)
Title
Measurements
OG0000.88± 1.41
OG001-0.40± 1.27
OG0020.64± 1.68
Severity Scale: C5D1 (n=23,34,29)
Title
Measurements
OG0000.72± 1.37
OG001-0.34± 1.59
OG0020.60± 2.13
Severity Scale: C6D1 (n=15,38,26)
Title
Measurements
OG0000.70± 1.80
OG0010.09± 1.44
OG0020.96± 1.60
Severity Scale: C7D1 (n=12,30,22)
Title
Measurements
OG0000.28± 1.51
OG001-0.16± 1.55
OG0020.26± 1.22
Severity Scale: C8D1 (n=17,29,22)
Title
Measurements
OG0000.28± 1.45
OG001-0.13± 1.56
OG0020.42± 1.74
Severity Scale: C9D1 (n=11,24,21)
Title
Measurements
OG000-0.15± 1.55
OG001-0.03± 1.67
OG0020.76± 1.50
Severity Scale: C10D1 (n=14,27,21)
Title
Measurements
OG0000.28± 1.37
OG0010.06± 1.52
OG0020.77± 1.52
Severity Scale: C11D1 (n=10,20,19)
Title
Measurements
OG0000.15± 1.57
OG001-0.05± 1.59
OG0020.57± 1.33
Severity Scale: C12D1 (n=11,23,16)
Title
Measurements
OG0000.32± 1.40
OG0010.47± 1.37
OG0020.38± 1.14
Severity Scale: C13D1 (n=8,13,12)
Title
Measurements
OG000-0.09± 1.43
OG0010.10± 1.35
OG0020.73± 1.55
Severity Scale: C14D1 (n=8,17,14)
Title
Measurements
OG0000.03± 0.81
OG0010.38± 1.48
OG002-0.05± 1.44
Severity Scale: C15D1 (n=7,11,9)
Title
Measurements
OG0000.28± 1.50
OG0010.42± 1.49
OG0020.71± 1.34
Severity Scale: C16D1 (n=7,17,14)
Title
Measurements
OG000-0.30± 0.88
OG0010.11± 1.46
OG0020.05± 2.08
Severity Scale: C17D1 (n=5,11,6)
Title
Measurements
OG000-0.20± 0.70
OG0010.21± 1.69
OG0020.72± 1.07
Severity Scale: C18D1 (n=6,14,9)
Title
Measurements
OG0000.02± 0.85
OG0010.31± 1.15
OG0020.61± 1.55
Severity Scale: C19D1 (n=4,8,16)
Title
Measurements
OG000-0.18± 0.54
OG0010.34± 1.42
OG0020.81± 2.32
Severity Scale: C20D1 (n=5,14,8)
Title
Measurements
OG000-0.06± 0.54
OG0010.15± 1.21
OG002-0.06± 1.67
Severity Scale: C21D1 (n=4,5,5)
Title
Measurements
OG000-0.25± 0.71
OG0010.27± 1.90
OG0021.20± 1.35
Severity Scale: C22D1 (n=3,11,8)
Title
Measurements
OG0000.57± 0.45
OG0010.81± 0.95
OG0020.09± 1.37
Severity Scale: C23D1 (n=4,5,3)
Title
Measurements
OG0000.30± 0.80
OG0010.64± 1.32
OG0021.05± 1.11
Severity Scale: C24D1 (n=5,11,7)
Title
Measurements
OG0000.91± 2.07
OG0010.37± 1.10
OG002-0.20± 1.62
Severity Scale: C25D1 (n=4,5,5)
Title
Measurements
OG0000.25± 0.96
OG001-0.03± 1.12
OG002-0.30± 1.63
Severity Scale: C26D1 (n=4,6,7)
Title
Measurements
OG000-0.05± 0.76
OG0010.46± 0.72
OG002-0.13± 1.79
Severity Scale: C27D1 (n=4,3,4)
Title
Measurements
OG000-0.21± 0.65
OG0010.07± 0.99
OG0020.34± 2.70
Severity Scale: C28D1 (n=4,5,7)
Title
Measurements
OG0000.12± 0.82
OG0010.74± 1.01
OG002-0.43± 2.00
Severity Scale: C29D1 (n=2,3,4)
Title
Measurements
OG0003.00± 2.12
OG001-0.14± 0.58
OG002-0.09± 2.51
Severity Scale: C30D1 (n=3,6,3)
Title
Measurements
OG0001.05± 1.70
OG0010.45± 1.05
OG0020.64± 0.68
Severity Scale: C31D1 (n=1,1,3)
Title
Measurements
OG000-0.50± NAStandard deviation was not estimable since only one participant was evaluable.
OG001-0.64± NAStandard deviation was not estimable since only one participant was evaluable.
OG0021.55± 1.69
Severity Scale: C32D1 (n=2,4,4)
Title
Measurements
OG0000.11± 0.25
OG0010.80± 0.93
OG0021.29± 1.03
Severity Scale: C33D1 (n=0,0,2)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG001NA± NAData was not analyzed as no participants were evaluable.
OG0020.89± 1.26
Severity Scale: C34D1 (n=2,4,3)
Title
Measurements
OG0000.04± 0.15
OG0010.75± 0.89
OG0020.43± 0.74
Severity Scale: C35D1 (n=0,0,1)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG001NA± NAData was not analyzed as no participants were evaluable.
OG0020.79± NAStandard deviation was not estimable since only one participant was evaluable.
Severity Scale: C36D1 (n=2,3,2)
Title
Measurements
OG0000.29± 0.51
OG0011.24± 1.22
OG002-0.18± 0.25
Severity Scale: C37D1 (n=0,1,0)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG0010.86± NAStandard deviation was not estimable since only one participant was evaluable.
OG002NA± NAData was not analyzed as no participants were evaluable.
Severity Scale: C38D1 (n=2,2,1)
Title
Measurements
OG0000.13± 0.28
OG0011.68± 1.97
OG0020.86± NAStandard deviation was not estimable since only one participant was evaluable.
Severity Scale: C39D1 (n=0,1,0)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG0010.86± NAStandard deviation was not estimable since only one participant was evaluable.
OG002NA± NAData was not analyzed as no participants were evaluable.
Severity Scale: C40D1 (n=2,2,2)
Title
Measurements
OG0000.18± 0.35
OG0011.29± 1.11
OG0020.43± 0.61
Severity Scale: C42D1 (n=2,2,1)
Title
Measurements
OG0000.18± 0.35
OG0011.25± 1.26
OG0020.00± NAStandard deviation was not estimable since only one participant was evaluable.
Severity Scale: Follow_Up (n=4,15,14)
Title
Measurements
OG0001.29± 2.75
OG001-0.00± 1.66
OG0020.29± 1.72
Interference Scale: Baseline (n=41,43,40)
Title
Measurements
OG0002.50± 2.70
OG0012.79± 2.57
OG0022.47± 2.66
Interference Scale: C2D1 (n=37,37,36)
Title
Measurements
OG0000.46± 1.80
OG001-0.08± 1.74
OG0020.78± 2.55
Interference Scale: C3D1 (n=31,38,30)
Title
Measurements
OG0000.60± 2.37
OG001-0.57± 1.88
OG0021.09± 2.37
Interference Scale: C4D1 (n=23,36,30)
Title
Measurements
OG0000.92± 2.16
OG001-0.54± 1.89
OG0021.15± 2.37
Interference Scale: C5D1 (n=23,34,29)
Title
Measurements
OG0000.65± 2.20
OG001-0.59± 1.98
OG0021.19± 2.90
Interference Scale: C6D1 (n=15,38,26)
Title
Measurements
OG0000.32± 2.01
OG001-0.18± 2.33
OG0020.99± 2.54
Interference Scale: C7D1 (n=12,30,22)
Title
Measurements
OG0000.43± 1.25
OG001-0.59± 2.13
OG0020.55± 2.05
Interference Scale: C8D1 (n=17,29,22)
Title
Measurements
OG0000.01± 1.58
OG001-0.10± 2.00
OG0020.48± 1.87
Interference Scale: C9D1 (n=11,24,21)
Title
Measurements
OG000-0.14± 1.08
OG001-0.39± 2.31
OG0020.75± 1.76
Interference Scale: C10D1 (n=14,27,21)
Title
Measurements
OG000-0.18± 1.80
OG0010.15± 2.06
OG0020.99± 2.12
Interference Scale: C11D1 (n=10,20,19)
Title
Measurements
OG0000.42± 1.23
OG001-0.51± 1.75
OG0020.84± 2.50
Interference Scale: C12D1 (n=10,23,16)
Title
Measurements
OG0000.03± 0.78
OG0010.17± 2.23
OG0020.38± 1.51
Interference Scale: C13D1 (n=8,13,12)
Title
Measurements
OG000-0.50± 1.56
OG001-0.31± 2.49
OG0020.31± 1.70
Interference Scale: C14D1 (n=8,17,14)
Title
Measurements
OG000-0.10± 0.84
OG0010.15± 2.57
OG0020.29± 2.12
Interference Scale: C15D1 (n=7,11,9)
Title
Measurements
OG000-0.52± 0.85
OG0010.27± 1.91
OG0020.70± 2.36
Interference Scale: C16D1 (n=7,17,14)
Title
Measurements
OG000-0.02± 0.33
OG001-0.48± 2.31
OG002-0.01± 2.38
Interference Scale: C17D1 (n=5,11,6)
Title
Measurements
OG000-0.90± 1.31
OG001-0.29± 3.16
OG0021.17± 1.28
Interference Scale: C18D1 (n=6,14,9)
Title
Measurements
OG0000.06± 0.34
OG0010.04± 2.38
OG0021.00± 2.26
Interference Scale: C19D1 (n=4,8,6)
Title
Measurements
OG0000.04± 0.34
OG0010.54± 2.25
OG0021.04± 1.84
Interference Scale: C20D1 (n=5,14,8)
Title
Measurements
OG0000.27± 0.65
OG001-0.08± 2.34
OG0020.35± 2.07
Interference Scale: C21D1 (n=4,5,5)
Title
Measurements
OG000-0.04± 0.86
OG001-0.97± 3.50
OG0021.83± 1.28
Interference Scale: C22D1 (n=3,11,8)
Title
Measurements
OG0000.44± 0.84
OG0010.74± 1.71
OG0020.83± 2.05
Interference Scale: C23D1 (n=4,5,3)
Title
Measurements
OG0000.21± 0.42
OG0011.13± 2.58
OG0021.28± 1.80
Interference Scale: C24D1 (n=5,11,7)
Title
Measurements
OG0002.00± 3.25
OG0010.30± 2.65
OG0020.55± 2.33
Interference Scale: C25D1 (n=4,5,5)
Title
Measurements
OG0000.00± 0.41
OG0010.10± 2.45
OG0020.90± 0.88
Interference Scale: C26D1 (n=4,6,7)
Title
Measurements
OG0000.33± 0.85
OG0010.67± 1.80
OG0020.33± 2.11
Interference Scale: C27D1 (n=4,3,4)
Title
Measurements
OG0000.04± 0.52
OG0010.11± 1.13
OG0021.63± 2.44
Interference Scale: C28D1 (n=4,5,7)
Title
Measurements
OG0000.71± 1.19
OG0010.97± 1.81
OG0020.19± 2.40
Interference Scale: C29D1 (n=2,3,4)
Title
Measurements
OG0003.25± 3.89
OG001-0.56± 0.96
OG0021.33± 2.97
Interference Scale: C30D1 (n=3,6,3)
Title
Measurements
OG0000.94± 1.49
OG0011.08± 2.16
OG0021.06± 1.83
Interference Scale: C31D1 (n=1,1,3)
Title
Measurements
OG0000.00± NAStandard deviation was not estimable since only one participant was evaluable.
OG001-0.17± NAStandard deviation was not estimable since only one participant was evaluable.
OG0022.33± 2.08
Interference Scale: C32D1 (n=2,4,4)
Title
Measurements
OG0000.08± 0.12
OG0011.50± 2.26
OG0022.17± 1.81
Interference Scale: C33D1 (n=0,0,2)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG001NA± NAData was not analyzed as no participants were evaluable.
OG0021.92± 2.71
Interference Scale: C34D1 (n=2,4,3)
Title
Measurements
OG0000.17± 0.24
OG0011.25± 1.89
OG0021.11± 1.51
Interference Scale: C35D1 (n=0,0,1)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG001NA± NAData was not analyzed as no participants were evaluable.
OG0021.67± NAStandard deviation was not estimable since only one participant was evaluable.
Interference Scale: C36D1 (n=2,3,2)
Title
Measurements
OG0000.17± 0.24
OG0011.89± 2.18
OG0021.33± 1.89
Interference Scale: C37D1 (n=0,1,0)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG0010.83± NAStandard deviation was not estimable since only one participant was evaluable.
OG002NA± NAData was not analyzed as no participants were evaluable.
Interference Scale: C38D1 (n=2,2,1)
Title
Measurements
OG0000.08± 0.12
OG0012.25± 2.47
OG002-0.17± NAStandard deviation was not estimable since only one participant was evaluable.
Interference Scale: C39D1 (n=0,1,0)
Title
Measurements
OG000NA± NAData was not analyzed as no participants were evaluable.
OG0010.50± NAStandard deviation was not estimable since only one participant was evaluable.
OG002NA± NAData was not analyzed as no participants were evaluable.
Interference Scale: C40D1 (n=2,2,2)
Title
Measurements
OG0000.42± 0.59
OG0012.50± 2.12
OG0020.25± 0.35
Interference Scale: C42D1 (n=2,2,1)
Title
Measurements
OG0000.25± 0.35
OG0012.58± 2.24
OG0020.00± NAStandard deviation was not estimable since only one participant was evaluable.