CP-751,871 In Combination With Docetaxel In Advance Non-h... | NCT01653158 | Trialant
NCT01653158
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 30, 2013Estimated
Enrollment
46Actual
Phase
Phase 1
Conditions
Advanced Non-Hematologic Malignancies
Interventions
CP-751,871
Docetaxel
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT01653158
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4021003
Secondary IDs
Not provided
Brief Title
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
Official Title
A Phase 1b Dose Escalation, Open-label Study Of CP-751,871 In Combination With Docetaxel In Advanced Non-hematologic Malignancies
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Oct 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
Mar 2005
Primary Completion Date
Feb 2009Actual
Completion Date
Feb 2009Actual
First Submitted Date
Jul 26, 2012
First Submission Date that Met QC Criteria
Jul 27, 2012
First Posted Date
Jul 30, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 18, 2013
Results First Submitted that Met QC Criteria
Jun 7, 2013
Results First Posted Date
Aug 27, 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
Oct 4, 2013
Last Update Posted Date
Oct 30, 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
This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Non-Hematologic Malignancies
Keywords
non-hematologic cancer
advanced solid tumors
prostrate cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
46Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CP-751,871 combined with docetaxel
Experimental
Drug: CP-751,871
Drug: Docetaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CP-751,871
Drug
CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.
Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD)
Cycle 1 Day 1 through Cycle 1 Day 21
Recommended Phase 2 Dose (RP2D)
Cycle 1 Day 1 through Cycle 1 Day 21
Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871
The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.
30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion
Other Outcomes
Measure
Description
Time Frame
Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years
Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
Eastern Cooperative Oncology Group [ECOG] performance status 0-1
Exclusion Criteria:
Significant active cardiac disease
Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
Inadequate bone marrow, renal, cardiac or liver function
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Sutton
Surrey
SM2 5PT
United Kingdom
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
FG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).
In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0069 subjects
FG00719 subjectsSix (6) and 13 participants were enrolled in dose escalation and expansion cohorts, respectively.
COMPLETED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Entire Study Population
Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose (MTD)
Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.
Posted
Number
mg/kg
Cycle 1 Day 1 through Cycle 1 Day 21
ID
Title
Description
OG000
CP-751,871 0.1-20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
Adverse Events Module
Frequency Threshold
0
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
C525021
figitumumab
D000077143
Docetaxel
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
Browse Leaves
Not provided
Browse Branches
Not provided
N/A
Intervention Model
Single Group 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
CP-751,871 combined with docetaxel
Docetaxel
Drug
Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.
CP-751,871 combined with docetaxel
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1
Maximum Observed Plasma Concentration (Cmax) divided by dose
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4
Maximum Observed Plasma Concentration (Cmax) divided by dose
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
Number of Participants With Objective Response (OR)
Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)
Time to Tumor Progression (TTP)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])
Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)
Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)
Systemic Clearance (CL) of CP-751,871 in Cycle 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Systemic Clearance (CL) of CP-751,871 in Cycle 4
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Volume of Distribution (Vz) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Volume of Distribution (Vz) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
Observed Accumulation Ratio (Rac) of CP-751,871
AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1
30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4
Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4
Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.
Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)
Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4
Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.
Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion
Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
2 subjects
FG0052 subjects
FG0067 subjects
FG0074 subjects
1 subjects
FG0051 subjects
FG0062 subjects
FG00715 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0079 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
46
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00059.4± 11.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
Male
BG00040
OG00033
Title
Denominators
Categories
Title
Measurements
OG000NATwo dose limiting toxicities (DLTs) were reported (a Grade 3 fatigue, reported in a subject receiving 10 mg/kg and Grade 4 hyperglycemia reported for a subject receiving 20 mg/kg), but MTD was not reached.
Primary
Recommended Phase 2 Dose (RP2D)
Safety analysis set: all enrolled participants who started treatment.
Posted
Number
mg/kg
Cycle 1 Day 1 through Cycle 1 Day 21
ID
Title
Description
OG000
CP-751,871 0.1-20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
Units
Counts
Participants
OG00046
Title
Denominators
Categories
Title
Measurements
OG00020
Primary
Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
nanogram*hour/millilitre (ng*hr/mL)
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG0002852.11± 943.017
Primary
Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng*hr/mL
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0002526.19± 925.815
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng*hr/mL
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG0002770.71± 946.869
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng*hr/mL
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0002438.34± 917.884
Primary
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng•hr/mL/(mg/m^2)
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG00036.9428± 12.6249
Primary
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng•hr/mL/(mg/m^2)
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00035.16± 11.1288
Primary
Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng/mL
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG0002656.92± 607.843
Primary
Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng/mL
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0002430± 497.343
Primary
Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1
Maximum Observed Plasma Concentration (Cmax) divided by dose
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng/mL/(mg/m^2)
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG00035.4256± 8.1046
Primary
Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4
Maximum Observed Plasma Concentration (Cmax) divided by dose
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
ng/mL/(mg/m^2)
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00035.3± 6.0377
Primary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
hr
30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG00013
Title
Denominators
Categories
Title
Measurements
OG0000.9179± 0.1833
Primary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4
Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.
Posted
Mean
Standard Deviation
hr
30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 20 mg/kg + Docetaxel
Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0000.8066± 0.1296
Secondary
Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871
The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.
All enrolled participants who started treatment and had evaluable HAHA data
Posted
Number
Participants
30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With Objective Response (OR)
Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.
Posted
Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Time to Tumor Progression (TTP)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])
This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).
Posted
Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.
Posted
Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Systemic Clearance (CL) of CP-751,871 in Cycle 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mL/day/kg
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00110.1± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0027.00± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG003
Secondary
Systemic Clearance (CL) of CP-751,871 in Cycle 4
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mL/day/kg
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG00070.6± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00112.90± 0.59
OG0026.84± NA
Secondary
Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg/L
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.34± 0.365
OG0017.81± 0.475
OG00217.9± 6.79
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg/L
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.29± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0016.91± 1.75
OG00217.8± 2.13
Secondary
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg*hr/L
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00038.4± 7.1
OG0011045± 236
OG0022040± 621
OG003
Secondary
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg*hr/L
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG001949± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0022744± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG003
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg*hr/L
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00022.3± 4.45
OG001673± 127
OG0021685± 879
OG003
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg*hr/L
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.6± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG001521± 37.1
OG0021728± 596
Secondary
Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
hr
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00168.5± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00297.4± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG003
Secondary
Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
hr
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.54± 0.067
OG0018.76± 12.0
OG0021.70± 0.146
OG003
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
hr
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.53± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0011.65± 0.109
OG0021.59± 0.119
Secondary
Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mL/kg
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00143.3± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00240.1± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG003
Secondary
Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.
Posted
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Volume of Distribution (Vz) of CP-751,871 in Cycle 1
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mL/kg
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00141.7± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00240.9± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG003
Secondary
Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Volume of Distribution (Vz) of CP-751,871 in Cycle 4
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1
Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.
This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.
Posted
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4
Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
mg*hr/L
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG00036.1± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG001745± 34.8
OG0022978± NA
Secondary
Observed Accumulation Ratio (Rac) of CP-751,871
AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort
Posted
Mean
Standard Deviation
Ratio
30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0002
OG0013
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.852± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0010.714± 0.236
OG0021.48± NA
Other Pre-specified
Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose
This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.
Posted
30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Other Pre-specified
Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4
Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose
This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.
Posted
30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4
Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.
All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.
Posted
Mean
Standard Deviation
mg/L
Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Day 22 of Cycle 1
Title
Measurements
OG0000± 0
OG0010± 0
OG0020.185± 0.320
OG003
Secondary
Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4
Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.
This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.
Posted
Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion
ID
Title
Description
OG000
CP-751,871 0.1 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
OG007
CP-751,871 20 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
2
3
3
3
EG001
CP-751,871 0.4 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
2
3
3
3
EG002
CP-751,871 0.8 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
2
3
3
3
EG003
CP-751,871 1.5 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
2
3
3
3
EG004
CP-751,871 3 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
1
3
3
3
EG005
CP-751,871 6 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
2
3
3
3
EG006
CP-751,871 10 mg/kg + Docetaxel
Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
7
9
9
9
EG007
CP-751,871 20 mg/kg + Docetaxel
In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
11
19
19
19
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0074 affected19 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Sinus bradycardia
Cardiac disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Colonic obstruction
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Constipation
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0073 affected19 at risk
Dysphagia
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0074 affected19 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Nausea
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Vomiting
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Disease progression
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Fatigue
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0063 affected9 at risk
EG0073 affected19 at risk
Pyrexia
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Clostridium difficile colitis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Gastroenteritis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Neutropenic sepsis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Pneumonia
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Sepsis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Skin infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Syncope
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Urinary retention
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Deep vein thrombosis
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Hypotension
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Orthostatic hypotension
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Syncope vasovagal
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0064 affected9 at risk
EG0074 affected19 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG00710 affected19 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0043 affected3 at risk
EG0053 affected3 at risk
EG0069 affected9 at risk
EG00716 affected19 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0064 affected9 at risk
EG0072 affected19 at risk
Sinus bradycardia
Cardiac disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Deafness
Ear and labyrinth disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Hearing impaired
Ear and labyrinth disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Cataract
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Conjunctivitis
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Dry eye
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Eye discharge
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Eye irritation
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Eye pain
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Eye pruritus
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Eyelid ptosis
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Keratitis
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Keratoconjunctivitis sicca
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Lacrimation increased
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0042 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Vision blurred
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Visual disturbance
Eye disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0064 affected9 at risk
EG0075 affected19 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Abdominal rigidity
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Abdominal tenderness
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Anal fissure
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Anal pruritus
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Constipation
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected3 at risk
EG0023 affected3 at risk
EG0032 affected3 at risk
EG0042 affected3 at risk
EG0052 affected3 at risk
EG0064 affected9 at risk
EG00713 affected19 at risk
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Dry mouth
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0074 affected19 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0053 affected3 at risk
EG0062 affected9 at risk
EG0071 affected19 at risk
Dysphagia
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Flatulence
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Gingival pain
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Haematemesis
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Nausea
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0033 affected3 at risk
EG0042 affected3 at risk
EG0051 affected3 at risk
EG0066 affected9 at risk
EG0077 affected19 at risk
Odynophagia
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Oral pain
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0073 affected19 at risk
Painful defaecation
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Proctalgia
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Rectal tenesmus
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Stomach discomfort
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Stomatitis
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Tongue disorder
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Toothache
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Vomiting
Gastrointestinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0042 affected3 at risk
EG0051 affected3 at risk
EG0066 affected9 at risk
EG0078 affected19 at risk
Catheter site rash
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Chest pain
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0072 affected19 at risk
Chills
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Fatigue
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected3 at risk
EG0023 affected3 at risk
EG0033 affected3 at risk
EG0041 affected3 at risk
EG0053 affected3 at risk
EG0069 affected9 at risk
EG00714 affected19 at risk
Influenza like illness
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Malaise
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Mucosal inflammation
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0063 affected9 at risk
EG0072 affected19 at risk
Oedema peripheral
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0071 affected19 at risk
Pain
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Pyrexia
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Ulcer
General disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Hepatomegaly
Hepatobiliary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Drug hypersensitivity
Immune system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Hypersensitivity
Immune system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Arthritis infective
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Candidiasis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Cellulitis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Ear infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Eye infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Gastroenteritis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Localised infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Oral candidiasis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Respiratory tract infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Rhinitis
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Skin candida
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Tooth abscess
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Tooth infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Urinary tract infection
Infections and infestations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Joint injury
Injury, poisoning and procedural complications
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Medical device pain
Injury, poisoning and procedural complications
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Alanine aminotransferase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0032 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Blood albumin
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Blood albumin decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0052 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0052 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Blood bilirubin increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Blood creatinine increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0042 affected3 at risk
EG0052 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Blood glucose increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0042 affected3 at risk
EG0052 affected3 at risk
EG0063 affected9 at risk
EG0071 affected19 at risk
Blood potassium decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Blood sodium decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Blood urea increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0052 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Blood urine present
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Gamma-glutamyltransferase abnormal
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Haemoglobin
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Lymphocyte count decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Neutrophil count increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0073 affected19 at risk
Platelet count decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0071 affected19 at risk
Transaminases increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Urine output decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Weight decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0075 affected19 at risk
White blood cell count decreased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0053 affected3 at risk
EG0067 affected9 at risk
EG0075 affected19 at risk
White blood cell count increased
Investigations
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0074 affected19 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0042 affected3 at risk
EG0052 affected3 at risk
EG0065 affected9 at risk
EG0077 affected19 at risk
Cachexia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0073 affected19 at risk
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Fluid retention
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0071 affected19 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0052 affected3 at risk
EG0062 affected9 at risk
EG0073 affected19 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0023 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0074 affected19 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0063 affected9 at risk
EG0070 affected19 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0072 affected19 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Dizziness
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Dysaesthesia
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Dysgeusia
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected3 at risk
EG0023 affected3 at risk
EG0032 affected3 at risk
EG0042 affected3 at risk
EG0051 affected3 at risk
EG0065 affected9 at risk
EG0073 affected19 at risk
Headache
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Hypoaesthesia
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Lethargy
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0073 affected19 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Neurotoxicity
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Paraesthesia
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0072 affected19 at risk
Sciatica
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Syncope
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Depressed mood
Psychiatric disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0072 affected19 at risk
Depression
Psychiatric disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Insomnia
Psychiatric disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0074 affected19 at risk
Panic attack
Psychiatric disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Bladder pain
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Enuresis
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Glycosuria
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Haematuria
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Nocturia
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Pollakiuria
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Polyuria
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Renal impairment
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Urinary hesitation
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Urinary retention
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Genital discharge
Reproductive system and breast disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Genital discomfort
Reproductive system and breast disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Gynaecomastia
Reproductive system and breast disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0062 affected9 at risk
EG0075 affected19 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0063 affected9 at risk
EG0075 affected19 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0064 affected9 at risk
EG0073 affected19 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0063 affected9 at risk
EG0073 affected19 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0071 affected19 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0041 affected3 at risk
EG0052 affected3 at risk
EG0066 affected9 at risk
EG0072 affected19 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0063 affected9 at risk
EG0073 affected19 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Periorbital oedema
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0071 affected19 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Walking disability
Social circumstances
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0070 affected19 at risk
Deep vein thrombosis
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Flushing
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected9 at risk
EG0070 affected19 at risk
Hypertension
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
Hypotension
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected9 at risk
EG0073 affected19 at risk
Lymphoedema
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Phlebitis
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0071 affected19 at risk
Varicose vein
Vascular disorders
MedDRA v11.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected9 at risk
EG0070 affected19 at risk
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.
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
1
OG0041
OG0053
OG0063
OG0070
0
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
2
OG0041
OG0050
OG0064
OG0071
6.67
± NA
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0049.23± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0065.17± 0.99
OG0073.53± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
1
OG0042
OG0052
OG0062
OG0074
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0033.05± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0042.74± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0052.68± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0064.01± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0072.70± 1.97
3
OG0043
OG0053
OG0069
OG0076
33.4
± 5.97
OG00457.7± 23.7
OG005129± 23.6
OG006205± 39.5
OG007382± 156
1
OG0042
OG0052
OG0067
OG0075
OG00354.7± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG004103± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG005188± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG006311± 65.5
OG007658± 185
3
OG0043
OG0053
OG0069
OG0075
5026
± 2516
OG00410570± 3369
OG00526215± 2520
OG00638160± 7757
OG00784916± 25982
0
OG0040
OG0050
OG0060
OG0070
2
OG0041
OG0050
OG0064
OG0071
6532
± NA
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0047799± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00647711± 9305
OG007136026± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
0
OG0040
OG0050
OG0060
OG0070
3
OG0043
OG0053
OG0069
OG0076
4568
± 2953
OG00410712± 3147
OG00526215± 2520
OG00639724± 8380
OG00778106± 37097
1
OG0042
OG0052
OG0067
OG0075
OG00311802± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00426329± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00555466± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00645521± 18562
OG007197090± 122305
2
OG0041
OG0050
OG0064
OG0071
151
± NA
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG004150± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG006224± 67
OG007174± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
0
OG0040
OG0050
OG0060
OG0070
3
OG0043
OG0053
OG0069
OG0076
9.41
± 12.7
OG0041.98± 0.060
OG0053.21± 0.336
OG00611.1± 11.5
OG0078.67± 7.51
1
OG0042
OG0052
OG0067
OG0075
OG0032.25± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00411.1± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0053.23± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0069.68± 10.71
OG0075.97± 0.296
2
OG0041
OG0050
OG0064
OG0071
52.9
± NA
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00483.2± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00667.5± 15.2
OG00737.5± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
2
OG0041
OG0050
OG0064
OG0071
55.1
± NA
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00483.1± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00667.9± 15.5
OG00736.8± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0042
OG0052
OG0062
OG0074
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00311802± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00426329± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00555466± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG00665711± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG007233578± 105208
1
OG0042
OG0052
OG0062
OG0073
Number of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0031.50± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0042.16± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0052.04± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0061.95± NANumber of participants analyzed was less than 3, and thus standard deviation was not calculated.
OG0072.00± 0.35
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
3
OG0043
OG0053
OG0069
OG0075
2.11
± 2.71
OG0049.07± 7.17
OG00530.4± 4.95
OG00637.7± 15.4
OG00784.5± 12.3
Day 22 of Cycle 4
Title
Measurements
OG0000± NANumber of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.
OG0010± 0
OG0020.144± NANumber of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.
OG00312.5± NANumber of participants analyzed was 1, which was less than 3, and thus standard deviation was not calculated.
OG00432.2± NANumber of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.
OG00547.2± NANumber of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.
OG00679.3± NANumber of participants analyzed was 2, which was less than 3, and thus standard deviation was not calculated.