Combination Study Of CP-751,871 With Paclitaxel And Carbo... | NCT00147537 | Trialant
NCT00147537
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 30, 2013Estimated
Enrollment
282Actual
Phase
Phase 1Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
CP-751,871
paclitaxel
carboplatin
CP-751,871
paclitaxel
carboplatin
erlotinib
Countries
United States
Canada
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT00147537
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4021002
Secondary IDs
Not provided
Brief Title
Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
Official Title
A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer
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
Feb 2005
Primary Completion Date
Aug 2011Actual
Completion Date
Aug 2011Actual
First Submitted Date
Sep 2, 2005
First Submission Date that Met QC Criteria
Sep 2, 2005
First Posted Date
Sep 7, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 18, 2013
Results First Submitted that Met QC Criteria
Mar 6, 2013
Results First Posted Date
Apr 24, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 8, 2012
Certification/Extension First Submitted that Passed QC Review
May 8, 2012
Certification/Extension First Posted Date
May 10, 2012Estimated
Last Update Submitted Date
Oct 1, 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
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib.
Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer
CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles
Phase 2 (Arms A & B)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b
The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.
Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
Recommended Phase 2 Dose (RP2D): Phase 1b
Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
Objective Response Rate: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate: Phase 1b
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of advanced/metastatic lung cancer
Exclusion Criteria:
Previous treatment with chemotherapy
Uncontrolled diabetes
History/active cardiovascular disease
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
Tucson
Arizona
85719
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Periods
Title
Milestones
Reasons Not Completed
Phase 1b
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
paclitaxel
Drug
Phase 2 Arm A:
Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
Phase 2 Arm B:
Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles
Phase 2 (Arms A & B)
carboplatin
Drug
Phase 2 Arm A:
Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
Phase 2 Arm B:
Carboplatin AUC 6, IV over 15-60 minutes up to 6 cycles
Phase 2 (Arms A & B)
CP-751,871
Drug
Phase 1b Dose Escalation/Expansion: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles) Phase 1b Erlotinib Extension: CP-751,871 20 mg/kg IV over 2.5 hours (up to 17 cycles)
Phase 1b
paclitaxel
Drug
Phase 1b Dose Escalation/Expansion: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles) Phase 1b Erlotinib Extension: paclitaxel 200 mg/m2, IV over 3 hours (up to 6 cycles)
Phase 1b
carboplatin
Drug
Phase 1b Dose Escalation/Expansion: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles) Phase 1b Erlotinib Extension: carboplatin AUC 6, IV over 15-60 minutes (up to 6 cycles)
Phase 1b
erlotinib
Drug
Phase 1b Erlotinib Extension: erlotinib 150 mg/day orally every day (up to 17 cycles)
Phase 1b
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b
HAHA are indicators of immunogenicity to CP-751,871.
Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)
Number of Circulating Endothelial Cells (CECs): Phase 1b
Day 1 pre-dose and Days 15 to 21 of Cycle 4
Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b
Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression
Day 1 pre-dose and Days 15 to 21 of Cycle 4
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
Cycle 2 pre-infusion (which is the end of Cycle 1)
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
Cycle 5 pre-infusion (which is the end of Cycle 4)
Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b
Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b
Maximum Observed Plasma Concentration
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b
Maximum Observed Plasma Concentration
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2
HAHA are indicators of immunogenicity to CP-751,871
Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion
M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2
The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. Total average score range: 0 to 10.
Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2
The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with '1' representing "not at all" and '4' "very much". Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.
Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)
Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2
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.
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2
Systemic clearance.
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2
Concentration at 504 hours post dose
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2
Maximum Observed Plasma Concentration
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Progression-Free Survival (PFS): Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Time to Progression (TTP) in Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Duration of Response (DR) in Phase 2
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
FG010
Paclitaxel(P)+Carboplatin(C) (Phase 2)
Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
FG01055 subjects55 randomized; 56 treated-1 randomized but not treated, 2 randomized to F+P+C rec'd P+C
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)
Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
BG002
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
BG003
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00043
BG00118
BG002166
BG00355
BG004282
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less than 65 years old (<65)
Title
Measurements
BG00027
BG00113
BG00282
BG003
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Female
Title
Measurements
BG00018
BG0018
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b
The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.
All participants who received at least one dose of any agent.
Posted
Number
mg/kg
Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)
Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG00042
Title
Denominators
Categories
Title
Measurements
OG000NACP-751,871 was safe and well tolerated at dose levels up to 20 mg/kg, and MTD was not reached.
Primary
Recommended Phase 2 Dose (RP2D): Phase 1b
All participants who received at least one dose of any agent.
Posted
Number
mg/kg
Start of treatment (baseline) up to the end of Cycle 1 (Day 21)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)
Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG000
Primary
Objective Response Rate: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment
Posted
Number
90% Confidence Interval
percentage of participants
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Primary
Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment
Posted
Number
90% Confidence Interval
percentage of participants
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Objective Response Rate: Phase 1b
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (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.
All participants who received at least one dose of any agent. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment
Posted
Number
percentage of participants
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)
Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Secondary
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b
HAHA are indicators of immunogenicity to CP-751,871.
All participants who received at least one dose of any agent. N=number of participants who were analyzed for HAHA
Posted
Number
number of participants
Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)
Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Number of Circulating Endothelial Cells (CECs): Phase 1b
Per protocol amendment 6, blood samples for the rapid quantification of CECs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.
Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG002
Secondary
Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b
Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression
Per protocol amendment 6, blood samples for the rapid quantification of CTCs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.
Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
milligram/liter (mg/L)
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg/L
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
milligram.hour/Liter (mg.hr/L)
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg.hr/L
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg.hr/L
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
Day
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Median
Standard Deviation
Day
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg/L
Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b
Concentration at 504 hours post dose
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg/L
Cycle 5 pre-infusion (which is the end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b
Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
ratio
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg.hr/L
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg.hr/L
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b
Maximum Observed Plasma Concentration
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg/L
Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b
Maximum Observed Plasma Concentration
All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics
Posted
Mean
Standard Deviation
mg/L
Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2
HAHA are indicators of immunogenicity to CP-751,871
All participants who received any of the study treatments. N=number of participants who were analyzed for HAHA
Posted
Number
number of participants
Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
Secondary
M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2
The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was "at its worst". Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was "as bad as you can imagine" or "interfered completely" with their life. Total average score range: 0 to 10.
Due to the status of the program, no participants were analyzed for MDASI in phase 2.
Posted
Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2
The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with '1' representing "not at all" and '4' "very much". Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.
Due to the status of the program, no participants were analyzed for EORTC-QLQ-C30/-LC13 in phase 2.
Posted
Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Secondary
Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2
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.
Volume of distribution (Vd) was not calculated based on the status of the program and the limited value this further pharmacokinetic analyses would provide.
Posted
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2
Systemic clearance.
Clearance (CL) were not calculated based on the status of the program and the limited value this further PK analyses would provide.
Posted
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Secondary
Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2
AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)
AUC504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.
Posted
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2
Concentration at 504 hours post dose
C504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.
Posted
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2
Maximum Observed Plasma Concentration
Cmax was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.
Posted
Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).
ID
Title
Description
OG000
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
OG001
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Secondary
Progression-Free Survival (PFS): Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
All participants who received any of the study treatments.
Posted
Median
90% Confidence Interval
months
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Single intravenous (IV) dose of CP-751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Time to Progression (TTP) in Phase 2
Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).
Due to the status of the program, time to progression was not was not analyzed.
Posted
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Single intravenous (IV) dose of CP-751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Secondary
Duration of Response (DR) in Phase 2
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Due to the status of the program, duration of response was not analyzed.
Posted
Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization
Single intravenous (IV) dose of CP-751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
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.
Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
9
17
17
17
EG009
CP-751,871 + Paclitaxel + Carboplatin (Phase 2)
Single intravenous (IV) dose of CP-751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
86
163
162
163
EG010
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
3
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG004
Neutropenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diplopia
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Disease progression
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mucosal haemorrhage
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Performance status decreased
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Death
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Multi-organ failure
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pneumonia necrotising
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diabetic complication
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Catatonia
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Personality disorder
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Leukocytoclastic vasculitis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vasculitis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0021 affected4 at risk
EG0030 affected3 at risk
EG0042 affected3 at risk
EG0050 affected3 at risk
EG0061 affected17 at risk
EG0074 affected7 at risk
EG0089 affected17 at risk
EG00956 affected163 at risk
EG01015 affected56 at risk
EG0114 affected22 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chalazion
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Eye disorder
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Eye irritation
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Eye swelling
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0022 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mucous stools
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected2 at risk
EG0021 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0022 affected4 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0021 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Catheter site pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected2 at risk
EG0021 affected4 at risk
EG003
Feeling cold
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Infusion site pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nodule
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Empyema
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Localised infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pneumonia 1
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Peroneal nerve injury
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Alanine aminotransferase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood calcium decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood chloride decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood creatinine
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood lactate dehydrogenase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood potassium increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood urea increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemoglobin
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Troponin
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0022 affected4 at risk
EG003
Weight increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
White blood cell count increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected2 at risk
EG0022 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0011 affected2 at risk
EG0021 affected4 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lower extremity mass
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscle rigidity
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Cerebral disorder
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected2 at risk
EG0022 affected4 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Parosmia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tremor
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected2 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected2 at risk
EG0021 affected4 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urogenital haemorrhage
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Scrotal erythema
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected2 at risk
EG0021 affected4 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hair growth abnormal
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected2 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0021 affected4 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pallor
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nodal arrhythmia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diplopia
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dental plaque
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Duodenogastric reflux
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gingival disorder
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Steatorrhoea
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tongue discolouration
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Disease progression
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Extravasation
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gravitational oedema
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Infusion site reaction
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Infusion site swelling
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Local swelling
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oedema
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Temperature intolerance
General disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Abscess limb
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Breast abscess
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Candidiasis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ear lobe infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Oral infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Post procedural diarrhoea
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Activated partial thromboplastin time
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bacterial test positive
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood albumin decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood chloride increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood glucose increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood immunoglobulin G increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood magnesium increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood pressure increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood sodium decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blood urine present
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Coagulation test abnormal
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Fungal test positive
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Glucose urine
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematocrit
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematocrit decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
International normalised ratio normal
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neutrophil count
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Occult blood positive
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Platelet count
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Protein total increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Protein urine present
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Red blood cell sedimentation rate
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Troponin I
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Troponin I increased
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urinary casts
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urine leukocyte esterase
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
White blood cell count
Investigations
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypouricaemia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Jaw disorder
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal disorder
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ageusia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Anosmia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tonic convulsion
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vocal cord paralysis
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Stress
Psychiatric disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Micturition disorder
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urethral haemorrhage
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nasal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Livedo reticularis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Denture wearer
Social circumstances
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Tooth repair
Surgical and medical procedures
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Haematoma
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Ischaemia
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Phlebitis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (v14.1)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected2 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C525021
figitumumab
D017239
Paclitaxel
D016190
Carboplatin
D000069347
Erlotinib Hydrochloride
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D056831
Coordination Complexes
D011799
Quinazolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0051 subjects
FG00614 subjects
FG0074 subjects
FG0084 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0095 subjects
FG0103 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG009161 subjects
FG01052 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00985 subjects
FG01031 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00912 subjects
FG0104 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00947 subjects
FG01012 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00916 subjects
FG0104 subjects
Randomized but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
33
BG004155
65 to 69 years old (65 - 69)
Title
Measurements
BG0006
BG0012
BG00242
BG00311
BG00461
70 years old and more than 70 years old (>=70)
Title
Measurements
BG00010
BG0012
BG00242
BG00311
BG00465
Unspecified
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
49
BG00321
BG00496
Male
Title
Measurements
BG00025
BG0019
BG002117
BG00334
BG004185
Unspecified
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
42
Title
Denominators
Categories
Title
Measurements
OG00020
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG00099
OG00151
Title
Denominators
Categories
Title
Measurements
OG00037.4(29.2 to 46.1)
OG00127.5(17.4 to 39.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
A one-sided p-value for H0: objective response rate <=0.28 using exact binomial test at level 0.05.
binomial test
=0.027
2-Sided
No
Superiority or Other
Units
Counts
Participants
OG00073
Title
Denominators
Categories
Title
Measurements
OG00037.0(27.5 to 47.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
A One-sided p-value for H0: objective response rate <=0.30 using exact binomial test at level 0.05.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0032
OG0041
OG0058
OG0063
OG0079
Title
Denominators
Categories
Title
Measurements
OG0002.975± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00119.15± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00240.70
OG003100.7± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0001
OG0014
OG0021
OG0032
OG0042
OG00510
OG0065
OG00717
Title
Denominators
Categories
Title
Measurements
OG00022.30
OG0012011± 1048.6
OG0025320
OG00312810± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00430500± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0032
OG0041
OG0057
OG0061
OG0076
Title
Denominators
Categories
Title
Measurements
OG00077.60
OG0012410± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00323200± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0013
OG0020
OG0032
OG0041
OG0054
OG0061
OG0077
Title
Denominators
Categories
Title
Measurements
OG0011434± 914.58
OG00316750± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0013
OG0020
OG0032
OG0041
OG0054
OG0061
OG0077
Title
Denominators
Categories
Title
Measurements
OG0012.84± 1.82
OG00310.81± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0012
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0015.360± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0014
OG0021
OG0032
OG0042
OG00511
OG0065
OG00717
Title
Denominators
Categories
Title
Measurements
OG0010.1610± 0.3220
OG0024.550
OG0039.820± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00428.20± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0032
OG0041
OG0057
OG0061
OG0077
Title
Denominators
Categories
Title
Measurements
OG0000.0000
OG0010.4630± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00327.70± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0032
OG0041
OG0057
OG0061
OG0076
Title
Denominators
Categories
Title
Measurements
OG0003.480
OG0011.009± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG0031.830± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0001
OG0012
OG0021
OG0032
OG0041
OG0059
OG0063
OG0079
Title
Denominators
Categories
Title
Measurements
OG00064.70
OG0012255± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG0022670
OG00323400± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0032
OG0041
OG0059
OG0063
OG00710
Title
Denominators
Categories
Title
Measurements
OG0002.975± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00120.25± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG00240.70
OG003100.7± NAAs planned, standard deviation was not calculated for the groups with fewer than 3 participants analyzed.
OG004327.0
OG005369.1± 91.602
OG006611.3± 43.501
OG007535.5± 180.97
Units
Counts
Participants
OG00038
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Units
Counts
Participants
OG0000
OG0010
Counts
Participants
OG0000
OG0010
OG002
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP-751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG00058
OG00149
OG00256
OG00356
Title
Denominators
Categories
Title
Measurements
OG0004.4(3.8 to 5.6)
OG0014.5(3.9 to 5.6)
OG0024.3(3.9 to 5.4)
OG0035.1(4.0 to 5.8)
OG002
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP-751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Paclitaxel + Carboplatin (Phase 2)
Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP-751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.